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Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults.
Vaccine. 2015 Jul 17; 33(31):3766-72.V

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.

Authors+Show Affiliations

Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: afix@path.org.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.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.The EMMES Corporation, 401N. Washington Street, Suite 700, Rockville, MD, 20850, USA. Electronic address: ldally@emmes.com.Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: jeflores@path.org.Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: grobertson@path.org.Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: jboslego@path.org.Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA. Electronic address: scryz@path.org.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26065919

Citation

Fix, Alan D., et al. "Safety and Immunogenicity of a Parenterally Administered Rotavirus VP8 Subunit Vaccine in Healthy Adults." Vaccine, vol. 33, no. 31, 2015, pp. 3766-72.
Fix AD, Harro C, McNeal M, et al. Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults. Vaccine. 2015;33(31):3766-72.
Fix, A. D., Harro, C., McNeal, M., Dally, L., Flores, J., Robertson, G., Boslego, J. W., & Cryz, S. (2015). Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults. Vaccine, 33(31), 3766-72. https://doi.org/10.1016/j.vaccine.2015.05.024
Fix AD, et al. Safety and Immunogenicity of a Parenterally Administered Rotavirus VP8 Subunit Vaccine in Healthy Adults. Vaccine. 2015 Jul 17;33(31):3766-72. PubMed PMID: 26065919.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults. AU - Fix,Alan D, AU - Harro,Clayton, AU - McNeal,Monica, AU - Dally,Len, AU - Flores,Jorge, AU - Robertson,George, AU - Boslego,John W, AU - Cryz,Stanley, Y1 - 2015/06/08/ PY - 2015/01/22/received PY - 2015/04/09/revised PY - 2015/05/12/accepted PY - 2015/6/13/entrez PY - 2015/6/13/pubmed PY - 2016/3/25/medline KW - Diarrhea KW - Non-replicating KW - Parenteral KW - Rotavirus KW - Subunit KW - Vaccine SP - 3766 EP - 72 JF - Vaccine JO - Vaccine VL - 33 IS - 31 N2 - 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/26065919/Safety_and_immunogenicity_of_a_parenterally_administered_rotavirus_VP8_subunit_vaccine_in_healthy_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(15)00656-8 DB - PRIME DP - Unbound Medicine ER -