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AIDS. 2019 Jul 10. doi: 10.1097/QAD.0000000000002310. [Epub ahead of print]

Long-term safety and vaccine-induced seropositivity in healthy volunteers from HIV vaccine trials: a French cohort study.

Author information

1
INSERM SC10-US019.
2
Université Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine.
3
INSERM, CIC 1417, F-CRIN, I-REIVAC.
4
CIC Cochin Pasteur, AP-HP, Hôpital Cochin.
5
Vaccine Research Institute, INSERM, U955.
6
Université Paris-Est Créteil Val de Marne (UPEC).
7
AP-HP, CHU Henri Mondor, Service d'Immunologie Clinique et Maladies Infectieuses.
8
Service de Médecine Interne, Hôpital Cochin, AP-HP.
9
Service des Maladies Infectieuses et Tropicales, Hôpital Tenon, AP-HP, Paris.
10
Service des Maladies Infectieuses et Tropicales, CHU Toulouse, Toulouse.
11
Service des Maladies Infectieuses et Tropicales, CHU Nantes, Nantes.
12
Aix Marseille Univ, APHM, INSERM, IRD, SESSTIM, Hôpital Sainte Marguerite, Service d'Immuno-Hématologie Clinique, Marseille.
13
Service de Recherche Vaccinale, ANRS.
14
Service de Pharmacovigilance, ANRS.
15
Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP UMRS 1136).
16
AP-HP, Hôpital Cochin, Unité de Biostatistique et Epidémiologie, Paris.
17
Université Aix-Marseille.
18
INSERM/IRD, UMR 912, Marseille.
19
Université Paris-Sud, Université Paris-Saclay.
20
AP-HP Hôpital Bicêtre, Paris, France.

Abstract

BACKGROUND:

The ANRS COV1-COHVAC cohort was a long-term safety cohort of healthy volunteers who received preventive HIV-vaccine candidates in 17 phase I/II clinical trials.

METHODS:

Data collected from the first vaccine candidate administration and annually after inclusion in the cohort included grade 3/4 adverse events and all grade adverse events suggestive of neurological, ophthalmological and immune disorders, self-administered questionnaires on behaviors and HIV ELISA results. Age-and-sex-standardized mortality rates (SMRs) were calculated with respect to the French population. The cohort was early terminated in 2016 due to the absence of safety signal.

RESULTS:

Of 496 volunteers, 488 were included: 355 in the 7-year prospective follow-up and 133 in the retrospective data collection only. The total follow-up after the first vaccination was 4934 person-years (median: 10 years) and 270 (76%) volunteers completed their follow-up. No relevant adverse event possibly related to the vaccine was reported. Breast cancer incidence and woman mortality did not differ from those of the French general population (standardized incidence ratio = 1.47, P = 0.45 and SMR = 0.65, P = 0.28, respectively) while man mortality was significantly lower (SMR = 0.26, P = 0.0003). At the last visit, 21/29 (72%) volunteers who received the recombinant HIV gp160 protein still showed vaccine-induced seropositivity after a median follow-up of 23 years. Only a few volunteers reported risky sexual practices (men: 20/192, women: 2/162).

CONCLUSION:

Volunteers showed a sustained high commitment. No long-term safety alert was identified during the postvaccine follow-up. Participating in vaccine trials did not increase risky behaviors for HIV infection. Vaccine-induced seropositivity may persist for more than 23 years after receiving rgp160.

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