Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV

Abstract

Objectives: To evaluate safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in adults living with HIV. Design: In this phase 3 study (V114-018; NCT03480802), pneumococcal vaccine-naive adults with HIV (CD4 + cell count ≥50 cells/μl, plasma HIV RNA <50 000 copies/ml, receiving antiretroviral therapy) were randomized 1 : 1 to receive one dose of V114 or licensed 13-valent PCV (PCV13) on day 1; participants received PPSV23 at week 8. Methods: Adverse events and serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were evaluated after each vaccination. Results: Of 302 participants enrolled, 292 (96.7%) completed the study. Proportions of participants experiencing at least one adverse event were 73.0 and 62.7% in the V114 and PCV13 groups following PCV and 60.7 and 71.6% following PPSV23. Most solicited adverse events were of mild or moderate severity and short duration. OPA geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs) were generally comparable between groups for shared serotypes at day 30 and maintained at week 12. OPA and IgG responses for additional serotypes in V114 (22F, 33F) were higher following V114 than PCV13 at day 30 but comparable at week 12, 30 days post-PPSV23. Conclusion: In pneumococcal vaccine-naive adults living with HIV, V114 was well tolerated and induced immune responses for all 15 pneumococcal serotypes. V114 can be followed by PPSV23 8 weeks later to broaden serotype coverage.

Pneumococcal vaccination—A literature review and practice guideline update

“…Most individuals in both vaccination groups reported at least one adverse event, most commonly injection‐site reactions (63.8% of patients receiving PCV15 and 54.7% receiving PCV13). The percentage of individuals with injection‐site reactions, systemic adverse events, and vaccine‐related adverse events was comparable 50 …”

“…In addition, the immune response elicited by PCV15 was found to be superior to PCV13 for the common serotype 3 and for serotypes 22F and 33F, both of which are unique to PCV15. Clinical trials revealed no significant difference in immune response in patients 65–74 and 75 years and older compared with younger individuals 48–55 . There are currently no published studies on the clinical effectiveness of PCV15.…”

“…There were no differences in the safety profile in patients 65–74 and 75 years and older compared with younger patients in clinical trials. Serious adverse reactions were extremely rare 30 days post‐vaccination (0.4% individuals receiving PCV15 vs. 0.7% individuals receiving PCV13) 48–55 …”

“…Clinical trials revealed no significant difference in immune response in patients 65-74 and 75 years and older compared with younger individuals. [48][49][50][51][52][53][54][55] There are currently no published studies on the clinical effectiveness of PCV15.…”

“…Similar to other pneumococcal conjugate vaccines, PCV15 is contraindicated in patients with a severe allergic reaction to any com- individuals receiving PCV13). [48][49][50][51][52][53][54][55] Data regarding the safety of PCV15 in pregnant and lactating women are currently lacking; however, animal toxicity studies have revealed no evidence of harm to the fetus. The safety profile of PCV15 in HIV-infected patients was similar to those who received PCV13 in one clinical trial.…”