This was a 1:1:1 randomized, double-blind trial of PCV-10 (Glaxo Smith-Kline), PPV-23 (Merck) and placebo (NCT02717494 ; status completed). The study was conducted at 8 NICHD clinical trial sites in Brazil under approval of national and local regulatory review boards. All participants signed informed consents before enrollment. The study planned to enroll 345 pregnant women with HIV, between ≥14 and <34 weeks gestational age. Key eligibility criteria were HIV infection, pregnancy between ≥14 and <34 weeks gestational age, being on ART at study entry, and ability to give informed consent. The gestational age at entry was assessed by ultrasound or date of last menstrual period. Immunization status was assessed by review of medical history and vaccination record. Data were not collected on study candidates who declined participation.
Ppv23
Manufactured by Merck Group
PPV23 is a pneumococcal polysaccharide vaccine manufactured by Merck Group. It contains purified capsular polysaccharides from 23 serotypes of Streptococcus pneumoniae.
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4 protocols using ppv23
1
Maternal Pneumococcal Vaccination During HIV
2
Pneumococcal Vaccine IgG Response
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In patients vaccinated with the 23-valent pneumococcal polysaccharide vaccine (pneumovax 23 Merck; PPV23), data on the serotype-specific IgG response were accessed retrospectively. In a standardized enzyme-linked immunosorbent assay, concentrations of antibodies against 6 serotypes: 1, 4, 7F, 14, 18C and 19F, and a geometric mean for all 6 serotypes combined were determined as described in detail previously.20 (link),21 (link) Children with an impaired response to half or more of the 6 tested serotypes were defined as having an impaired response.22 (link)–24 (link)
3
Immunization Protocols for NP-Ficoll, VLPs, and PPV23
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16–30-wk-old mice were i.p. immunized with 50 μg of NP-Ficoll (Biosearch Technologies) in 200 μl. For VLP immunization, mice 12–18 wk of age were injected i.p. with 2 μg/250 μl VLPs or 250 μl 1× PBS. VLPs were provided by B. Hou (Chinese Academy of Sciences, Beijing, China). For PPV23 (Merck) injection, mice were injected with 0.125 μg/200 μl i.p. per mouse or 200 μl 1× PBS.
4
Assessing PPV23 Vaccine Immune Response
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All children in both studies received a single sub-cutaneous dose (0.5 ml) of PPV23 (Merck, Sharp and Dohme, West Point, PA). In Study 1, blood samples (2 ml) were drawn from each child immediately before vaccination, then at 5, 7, 9, 11, 14 and 28 days after vaccination. Analysis of this first study suggested that the optimal days for observing the speed of response, if constrained to two sample points, were days 7 and 11. In Study 2 therefore, blood samples were drawn from each child before vaccination and 7 and 11 days after the vaccination. Serum was separated from the blood samples and stored at −80 °C until tested. Pre- and post-immunization sera from each individual were tested on the same ELISA plate.
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