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Rapid Responses to 2 Virus-Like Particle Norovirus Vaccine Candidate Formulations in Healthy Adults: A Randomized Controlled Trial
- Source :
- Journal of Infectious Diseases. 214:845-853
- Publication Year :
- 2016
- Publisher :
- Oxford University Press (OUP), 2016.
-
Abstract
- Background. Noroviruses pose a significant public health risk, particularly in very young individuals, older adults, and individuals with underlying conditions. We assessed 2 bivalent norovirus virus-like particle (VLP) vaccine candidate formulations in healthy adults aged 18–49 years. Methods. Enrolled subjects (n = 454) randomly assigned among 3 groups received intramuscular placebo (saline) or vaccines containing either 15 µg or 50 µg of GI.1 VLP and 50 µg GII.4 VLP (15/50 and 50/50 formulations) adjuvanted with monophosphoryl lipid A and Al(OH)3. We present safety and immunogenicity assessments up to 28 days after vaccination. Results. No vaccine-related serious adverse events or adverse events of special interest were reported. Reactions were mainly mild to moderate, the most frequent being transient pain, in 8%, 64%, and 73% of placebo, 15/50, and 50/50 groups, respectively; transient myalgia, headache, and fatigue were the commonest systemic adverse events. Subjects assessed per protocol (n = 442) displayed rapid immune responses to vaccination, peaking by days 7–10 and persisting through day 28. GI.1 responses were highest with the 50/50 formulation, but GII.4 responses were higher with the 15/50 formulation. Conclusions. Both candidate VLP vaccines were well tolerated and elicited robust immune responses by 7–10 days that persisted through day 28. The 15/50 formulation displayed the best balance of tolerability and immunogenicity. Clinical Trials Registration. {"type":"clinical-trial","attrs":{"text":"NCT02142504","term_id":"NCT02142504"}}NCT02142504.
- Subjects :
- Adult
Male
0301 basic medicine
myalgia
medicine.medical_specialty
Time Factors
Adolescent
Drug-Related Side Effects and Adverse Reactions
viruses
030106 microbiology
Monophosphoryl Lipid A
Antibodies, Viral
Placebo
Injections, Intramuscular
law.invention
Placebos
Major Articles and Brief Reports
Young Adult
03 medical and health sciences
fluids and secretions
0302 clinical medicine
Adjuvants, Immunologic
Double-Blind Method
Randomized controlled trial
law
Internal medicine
medicine
Humans
Immunology and Allergy
Vaccines, Virus-Like Particle
030212 general & internal medicine
Adverse effect
Caliciviridae Infections
business.industry
Immunogenicity
Norovirus
Virion
virus diseases
Middle Aged
Healthy Volunteers
Immunoglobulin A
Vaccination
Infectious Diseases
Tolerability
Female
medicine.symptom
business
Subjects
Details
- ISSN :
- 15376613 and 00221899
- Volume :
- 214
- Database :
- OpenAIRE
- Journal :
- Journal of Infectious Diseases
- Accession number :
- edsair.doi.dedup.....ae67e2b02b0a0619c7aee28c74e23545