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Vaccine. 2015 Jul 17;33(31):3766-72. doi: 10.1016/j.vaccine.2015.05.024. Epub 2015 Jun 8.

Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults.

Author information

1
Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: afix@path.org.
2
Center for Immunization Research, Department of International Health, The Johns Hopkins Bloomberg School of Public Health, 624N. Broadway, Suite 117, Hampton House, Baltimore, MD 21205, USA.
3
Laboratory for Specialized Clinical Studies, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, 333 Burnet Avenue ML6014, Cincinnati, OH, 45229, USA. Electronic address: Monica.McNeal@cchmc.org.
4
The EMMES Corporation, 401N. Washington Street, Suite 700, Rockville, MD, 20850, USA. Electronic address: ldally@emmes.com.
5
Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: jeflores@path.org.
6
Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: grobertson@path.org.
7
Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: jboslego@path.org.
8
Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: scryz@path.org.

Abstract

BACKGROUND:

The P2-VP8 subunit vaccine for the prevention of rotavirus gastroenteritis is comprised of a truncated VP8 subunit protein from the rotavirus Wa strain (G1[P8]) fused to the tetanus toxin P2 epitope, and adsorbed on aluminum hydroxide for intramuscular administration.

METHODS:

Three groups of 16 adults were randomized to receive three injections of P2-VP8 (12) or placebo (4) at doses of 10, 30 or 60 μg of vaccine. IgG and IgA antibodies to P2-VP8 were assessed by ELISA in serum and lymphocyte supernatant (ALS). Serum samples were tested for neutralizing antibodies to homologous and heterologous strains of rotavirus.

RESULTS:

The vaccine was well-tolerated. All vaccine recipients demonstrated significant IgA responses and all but one demonstrated IgG responses; in the 60 μg cohort, geometric mean titers (GMTs) rose 70- and 80-fold for IgA and IgG, respectively. Homologous neutralizing antibody responses were observed in about half of participants in all three dose cohorts; in the 60 μg cohort, GMTs against Wa rose from 128 to 992. Neutralizing antibody responses were robust to P[8] strains, moderate to P[4] strains and negligible to P[6] strains. ALS IgA responses were dose dependent.

CONCLUSIONS:

The P2-VP8 subunit vaccine was well tolerated and evoked promising immune responses.

CLINICAL TRIALS REGISTRATION:

NCT01764256.

KEYWORDS:

Diarrhea; Non-replicating; Parenteral; Rotavirus; Subunit; Vaccine

PMID:
26065919
DOI:
10.1016/j.vaccine.2015.05.024
[Indexed for MEDLINE]
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