The adult-specific 21-valent pneumococcal conjugate vaccine (V116) is well tolerated, and all 21 serotypes are immunogenic among patients with HIV infection. These findings were published in The Lancet HIV.
Compared with patients without HIV, those with HIV have pneumococcal disease and pneumococcal pneumonia rates that are about 30 times higher, making effective vaccination imperative in HIV care.
Researchers conducted a 2-part phase 3 randomized, double-blind, active comparator-controlled study (STRIDE-7; ClinicalTrials.gov Identifier: NCT05393037) at 20 sites in 6 countries across 5 continents between 2022 and 2024. Adults with HIV who received combination antiretroviral therapy were randomly assigned 1:1 to receive V116 followed by placebo at 8 weeks (n=156) or the 15-valent pneumococcal conjugate vaccine (PCV15) followed by the 23-valent pneumococcal polysaccharide vaccine (PPSV23; n=156). After follow-up, V116 recipients could receive open-label PCV15. The primary outcome was serotype-specific opsonophagocytic activity geometric mean titers (GMTs) at 30 days.
The V116 and comparator cohorts comprised 73% and 69% men, mean (SD) ages were 44 (13) and 47 (12) years, 45% and 51% were White, 81% and 85% had an undetectable HIV viral load, and 64% and 63% were naive to both PCV13 and PPSV23 vaccines, respectively.
At day 30, the V116 recipients had GMTs for all 21 serotypes in the vaccine. Additionally, V116 recipients had similar GMTs as the comparator group at week 12 for the 13 serotypes that were common between vaccination regimens.
The immunoglobulin G responses to V116 were consistent with GMT trends.
The immunogenic profile of V116 was robust to age, gender, race, ethnicity, CD4+ count, and pneumococcal vaccination history, but GMTs in both study arms were higher among adults aged 49 years or younger and those with a CD4+ count of at least 500 cells/mL.
The exploratory analysis confirmed PCV15 immunogenic effects after V116 receipt.
Most patients in the V116 and comparator groups had at least 1 adverse event (72% vs 91%) and vaccine-related adverse events (62% vs 88%), but no vaccine-related serious adverse events occurred, respectively. In the V116 group, the most common events were injection-site pain (50%), fatigue (30%), and headache (25%).
One serious adverse event of presyncope occurred after receipt of PCV15 after V116 vaccination.
One death of unknown cause occurred 65 days after V116 receipt and was deemed unrelated with the experimental vaccine.
Study limitations include small sample sizes and reduced generalizability.
The researchers concluded, “Adults at high risk for pneumococcal disease due to underlying comorbid conditions, such as HIV, might benefit from receiving V116.”
Disclosure: This research was supported by MSD. Please see the original reference for a full list of disclosures.
By Jessica Nye, PhD
References:
Pathirana J, Ramgopal M, Martin C, et al. Safety, tolerability, and immunogenicity of an adult-specific pneumococcal conjugate vaccine, V116, in people living with HIV (STRIDE-7): a two-part, parallel-group, randomised, active comparator-controlled, international, phase 3 trial. Lancet HIV. Published online September 12, 2025. doi:10.1016/S2352-3018(25)00165-1
Source : Infectious Disease Advisor
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