Tags

Type your tag names separated by a space and hit enter

Norovirus vaccine against experimental human Norwalk Virus illness.
N Engl J Med. 2011 Dec 08; 365(23):2178-87.NEJM

Abstract

BACKGROUND

Noroviruses cause epidemic and sporadic acute gastroenteritis. No vaccine is available to prevent norovirus illness or infection.

METHODS

We conducted a randomized, double-blind, placebo-controlled, multicenter trial to assess the safety, immunogenicity, and efficacy of an investigational, intranasally delivered norovirus viruslike particle (VLP) vaccine (with chitosan and monophosphoryl lipid A as adjuvants) to prevent acute viral gastroenteritis after challenge with a homologous viral strain, Norwalk virus (genotype GI.1). Healthy adults 18 to 50 years of age received two doses of either vaccine or placebo and were subsequently inoculated with Norwalk virus and monitored for infection and gastroenteritis symptoms.

RESULTS

Ninety-eight persons were enrolled and randomly assigned to receive vaccine (50 participants) or placebo (48 participants), and 90 received both doses (47 participants in the vaccine group and 43 in the placebo group). The most commonly reported symptoms after vaccination were nasal stuffiness, nasal discharge, and sneezing. Adverse events occurred with similar frequency among vaccine and placebo recipients. A Norwalk virus-specific IgA seroresponse (defined as an increase by a factor of 4 in serum antibody levels) was detected in 70% of vaccine recipients. Seventy-seven of 84 participants inoculated with Norwalk virus were included in the per-protocol analysis. Vaccination significantly reduced the frequencies of Norwalk virus gastroenteritis (occurring in 69% of placebo recipients vs. 37% of vaccine recipients, P=0.006) and Norwalk virus infection (82% of placebo recipients vs. 61% of vaccine recipients, P=0.05).

CONCLUSIONS

This norovirus VLP vaccine provides protection against illness and infection after challenge with a homologous virus. (Funded by LigoCyte Pharmaceuticals and the National Institutes of Health; ClinicalTrials.gov number, NCT00973284.).

Authors+Show Affiliations

Baylor College of Medicine, Houston, TX 77030, USA. ratmar@bcm.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22150036

Citation

Atmar, Robert L., et al. "Norovirus Vaccine Against Experimental Human Norwalk Virus Illness." The New England Journal of Medicine, vol. 365, no. 23, 2011, pp. 2178-87.
Atmar RL, Bernstein DI, Harro CD, et al. Norovirus vaccine against experimental human Norwalk Virus illness. N Engl J Med. 2011;365(23):2178-87.
Atmar, R. L., Bernstein, D. I., Harro, C. D., Al-Ibrahim, M. S., Chen, W. H., Ferreira, J., Estes, M. K., Graham, D. Y., Opekun, A. R., Richardson, C., & Mendelman, P. M. (2011). Norovirus vaccine against experimental human Norwalk Virus illness. The New England Journal of Medicine, 365(23), 2178-87. https://doi.org/10.1056/NEJMoa1101245
Atmar RL, et al. Norovirus Vaccine Against Experimental Human Norwalk Virus Illness. N Engl J Med. 2011 Dec 8;365(23):2178-87. PubMed PMID: 22150036.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Norovirus vaccine against experimental human Norwalk Virus illness. AU - Atmar,Robert L, AU - Bernstein,David I, AU - Harro,Clayton D, AU - Al-Ibrahim,Mohamed S, AU - Chen,Wilbur H, AU - Ferreira,Jennifer, AU - Estes,Mary K, AU - Graham,David Y, AU - Opekun,Antone R, AU - Richardson,Charles, AU - Mendelman,Paul M, PY - 2011/12/14/entrez PY - 2011/12/14/pubmed PY - 2011/12/21/medline SP - 2178 EP - 87 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 365 IS - 23 N2 - BACKGROUND: Noroviruses cause epidemic and sporadic acute gastroenteritis. No vaccine is available to prevent norovirus illness or infection. METHODS: We conducted a randomized, double-blind, placebo-controlled, multicenter trial to assess the safety, immunogenicity, and efficacy of an investigational, intranasally delivered norovirus viruslike particle (VLP) vaccine (with chitosan and monophosphoryl lipid A as adjuvants) to prevent acute viral gastroenteritis after challenge with a homologous viral strain, Norwalk virus (genotype GI.1). Healthy adults 18 to 50 years of age received two doses of either vaccine or placebo and were subsequently inoculated with Norwalk virus and monitored for infection and gastroenteritis symptoms. RESULTS: Ninety-eight persons were enrolled and randomly assigned to receive vaccine (50 participants) or placebo (48 participants), and 90 received both doses (47 participants in the vaccine group and 43 in the placebo group). The most commonly reported symptoms after vaccination were nasal stuffiness, nasal discharge, and sneezing. Adverse events occurred with similar frequency among vaccine and placebo recipients. A Norwalk virus-specific IgA seroresponse (defined as an increase by a factor of 4 in serum antibody levels) was detected in 70% of vaccine recipients. Seventy-seven of 84 participants inoculated with Norwalk virus were included in the per-protocol analysis. Vaccination significantly reduced the frequencies of Norwalk virus gastroenteritis (occurring in 69% of placebo recipients vs. 37% of vaccine recipients, P=0.006) and Norwalk virus infection (82% of placebo recipients vs. 61% of vaccine recipients, P=0.05). CONCLUSIONS: This norovirus VLP vaccine provides protection against illness and infection after challenge with a homologous virus. (Funded by LigoCyte Pharmaceuticals and the National Institutes of Health; ClinicalTrials.gov number, NCT00973284.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/22150036/full_citation L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa1101245?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -