Abstract
BackgroundPregnancies occur during HIV-1 vaccine clinical trials, despite requirements for women of reproductive potential to use effective contraception. Deployment of an effective HIV-1 vaccine regimen will likely target adolescents and young adults and therefore safety for pregnant and breastfeeding women will need to be addressed.MethodsWe performed a retrospective, cross-protocol analysis to identify and compare pregnancy outcomes reported in 53 Phase 1 and Phase 2a HIV-1 vaccine clinical trials conducted by the HIV Vaccine Trials Network (HVTN).ResultsTwo thousand six hundred seventy-three women of reproductive potential were identified and 193 pregnancies were reported. 39 of 53 (74%) studies had at least one pregnancy reported with an overall pregnancy rate of 3.15 per 100 woman-years (w-yr). While active contraception use was required during study participation, 13 of the 53 studies also contained a long-term follow up period during which pregnancy was no longer discouraged. The pregnancy rate during main study participation was 3.09 per 100 w-yr, while pregnancies occurred at a slightly greater rate in the long-term follow up period (3.22 per 100 w-yr). Adverse pregnancy outcomes were reported at similar rates between vaccinees and placebo recipients when vaccine vectors, adjuvant used, or geographic region were examined.ConclusionAlthough there is considerable heterogeneity amongst the different vaccine trials, there appears to be no obvious indication of increased risk of adverse pregnancy or birth outcomes in these early phase HIV-1 vaccine studies. More complete data on pregnancy outcomes should be collected in early phase HIV-1 vaccine clinical trials to better inform subsequent efficacy trials.
Highlights
Some significant progress has been made this decade to develop a safe and effective vaccine that protects against HIV infection
Studies included We reviewed data collected during 53 completed HIV Vaccine Trials Network (HVTN) Human immunodeficiency virus type 1 (HIV-1) vaccine Phase 1 and 2a clinical trials conducted from March 27, 2001 and unblinded by December 31, 2018
While contraception use was required in all trials, those data are not presented in this analysis; the most recent contraception use and/or cessation of contraceptive usage was not collected on pregnancy-related Case report form (CRF)
Summary
Some significant progress has been made this decade to develop a safe and effective vaccine that protects against HIV infection. Investigators exclude pregnant and breastfeeding women from participating and require women of reproductive potential to use effective contraception throughout the vaccination phase of the trial. These restrictions may deter women from enrolling in HIV vaccine trials or lead to discontinuation of vaccination prior to receipt of the full regimen or early study attrition for those who do enroll [9, 10]. Pregnancies occur during HIV-1 vaccine clinical trials, despite requirements for women of reproductive potential to use effective contraception. Deployment of an effective HIV-1 vaccine regimen will likely target adolescents and young adults and safety for pregnant and breastfeeding women will need to be addressed
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