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Clinical Research and Public HealthIn-Press PreviewAIDS/HIVClinical Research Open Access | 10.1172/JCI186927

Safety and implementation of phase 1 randomized GLA-SE-adjuvanted CH505TF gp120 HIV vaccine trial in newborns

Avy Violari,1 Kennedy Otwombe,1 William Hahn,2 Shiyu Chen,2 Deirdre Josipovic,1 Vuyelwa Baba,3 Asimenia Angelidou,4 Kinga K. Smolen,4 Ofer Levy,4 Nonhlanhla N. Mkhize,5 Amanda S. Woodward Davis,2 Troy M. Martin,2 Barton F. Haynes,6 Wilton B. Williams,7 Zachary K. Sagawa,8 James G. Kublin,2 Laura Polakowski,9 Margaret Brewinski Isaacs,9 Catherine Yen,9 Georgia Tomaras,10 Lawrence Corey,2 Holly Janes,2 and Glenda E. Gray1

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Violari, A. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Otwombe, K. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Hahn, W. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Chen, S. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Josipovic, D. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Baba, V. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Angelidou, A. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Smolen, K. in: JCI | PubMed | Google Scholar |

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Levy, O. in: JCI | PubMed | Google Scholar |

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Mkhize, N. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Woodward Davis, A. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Martin, T. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Haynes, B. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Williams, W. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Sagawa, Z. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Kublin, J. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Polakowski, L. in: JCI | PubMed | Google Scholar |

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Brewinski Isaacs, M. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Yen, C. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Tomaras, G. in: JCI | PubMed | Google Scholar |

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Corey, L. in: JCI | PubMed | Google Scholar |

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Janes, H. in: JCI | PubMed | Google Scholar

1Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, United States of America

3Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

4Precision Vaccines Program, Boston Children’s Hospital, Boston, United States of America

5SA MRC Antibody Immunity Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

6Department of Integrative Immunobiology, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

7Department of Surgery, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, United States of America

8Access to Advanced Health Institute, Seattle, United States of America

9National Institute of Allergy and Infectious Diseases, NIH, Rockville, United States of America

10Center for Human Systems Immunology, Departments of Surgery, Immunology, Mo, Duke University, Durham, United States of America

Find articles by Gray, G. in: JCI | PubMed | Google Scholar

Published April 3, 2025 - More info

J Clin Invest. https://doi.org/10.1172/JCI186927.
Copyright © 2025, Violari et al. This work is licensed under the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
Published April 3, 2025 - Version history
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Abstract

BACKGROUND. The neonatal immune system is uniquely poised to generate broadly neutralizing antibodies (bnAbs) and thus infants are ideal for evaluating HIV vaccine candidates. We present the design and safety of a new-in-infants glucopyranosyl lipid A (GLA)-stable emulsion (SE) adjuvant admixed with a first-in-infant CH505 transmitter-founder (CH505TF) gp120 immunogen designed to induce precursors for bnAbs against HIV.

METHODS. HVTN 135 is a phase I randomized, placebo-controlled trial of CH505TF+GLA-SE or placebo. Healthy infants aged ≤ 5 days, born to mothers living with HIV but HIV nucleic acid negative at birth were randomized to five doses of CH505TF + GLA-SE or placebo at birth and 8, 16, 32, and 54 weeks.

RESULTS. 38 infants (median age = 4 days; interquartile range 4, 4.75 days) were enrolled November 2020 to January 2022. Among 28 (10) infants assigned to receive CH505TF + GLA-SE (placebo), most (32/38) completed the 5-dose immunization series and follow-up (35/38). Solicited local and systemic reactions were more frequent in vaccine (8, 28.6% local; 16, 57.1% systemic) vs. placebo recipients (1, 10% local, P = 0.25; 4, 40.0% systemic, P = 0.38). All events were Grade 1 except two Grade 2 events (pain, lethargy). Serious vaccine-related adverse events were not recorded.

CONCLUSIONS. This study illustrates the feasibility of conducting trials of new-in-infants adjuvanted HIV vaccines in HIV-exposed infants receiving standard infant vaccinations. The safety profile of the CH505TF + GLA-SE vaccine was reassuring.

TRIAL REGISTRATION. ClinicalTrials.gov NCT04607408.

FUNDING. The trial was funded through National Institute of Allergy and Infectious Disease of the National Institutes of Health under grants UM1 AI068614 (HVTN Leadership and Operations Center), UM1 AI068635 (HVTN Statistical and Data Management Center), and UM1 AI068618 (HVTN Laboratory Center).

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  • Version 1 (April 3, 2025): In-Press Preview
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