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Clinical Trial
. 2021 May 4;17(5):1463-1469.
doi: 10.1080/21645515.2020.1810493. Epub 2020 Nov 11.

Safety, reactogenicity, and immunogenicity of a 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine in healthy toddlers: results from a phase I, randomized trial

Michael Horn  1 , Ulrich Behre  2 , Magali Traskine  3 , Kurt Dobbelaere  3 , Dorota Borys  3
Affiliations
Clinical Trial

Safety, reactogenicity, and immunogenicity of a 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine in healthy toddlers: results from a phase I, randomized trial

Michael Horn et al. Hum Vaccin Immunother. .

Abstract

As a stepping stone toward evaluation in infants, the safety and immunogenicity of an investigational 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (12vPHiD-CV) was assessed in toddlers. 12vPHiD-CV contains CRM197-conjugated capsular polysaccharides of serotypes 6A and 19A in addition to capsular polysaccharides of the 10 serotypes in PHiD-CV. In this phase I, double-blind, multicenter study (NCT01485406) conducted in Germany, 61 healthy toddlers aged 12-23 months previously primed with three PHiD-CV doses were randomized (1:1) to receive one dose of 12vPHiD-CV or PHiD-CV. Safety and reactogenicity of 12vPHiD-CV were assessed in terms of occurrence of grade 3 vaccination-related solicited and unsolicited adverse events (AEs) and vaccination-related serious AEs. Immune responses were evaluated 1 month post-vaccination. Grade 3 solicited local AEs (all considered vaccination-related) were reported for two (6.5%, redness) and three (9.7%, swelling) toddlers in the 12vPHiD-CV group and one (3.4%, swelling) in the PHiD-CV group. Grade 3 vaccination-related solicited general AEs were only reported in the PHiD-CV group. No grade 3 unsolicited or serious AEs were reported. For PHiD-CV serotypes, 100% of toddlers in both groups had antibody concentrations ≥0.2 µg/mL 1 month post-vaccination, and antibody geometric mean concentrations increased from pre-boosting. For serotypes 6A and 19A, antibody responses tended to be higher in the 12vPHiD-CV than the PHiD-CV group. A single dose of 12vPHiD-CV administered in toddlers was well tolerated and no safety concerns were identified. Immune responses were comparable to those induced by PHiD-CV when administered in toddlers previously primed with three doses of PHiD-CV.

Keywords: PHiD-CV; Pneumococcal conjugate vaccine; booster dose; immunogenicity; safety; toddlers.

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Conflict of interest statement

MT and DB are employed by the GSK group of companies. KD was employed by the GSK group of companies. DB and KD hold shares in the GSK group of companies. MH received a grant from the GSK group of companies for study conduct. UB has nothing to disclose.

Figures

Figure 1.
Figure 1.
Participant flow chart
Figure 2.
Figure 2.
Percentage of toddlers with solicited local (A) and general (B) adverse events within the 7-day period following vaccination (total vaccinated cohort)
See this image and copyright information in PMC

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