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

Vaccine

Volumn 33, Issue 31, 2015, Pages 3766-3772

  Fix, Alan D ^a   Harro, Clayton ^b   McNeal, Monica ^c   Dally, Len ^d   Flores, Jorge ^a   Robertson, George ^a   Boslego, John W ^a,e   Cryz, Stanley ^a  

^a PATH   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^d EMMES CORPORATION   (United States)

^e Takeda Vaccines   (United States)

Author keywords

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

Indexed keywords

ALUMINUM HYDROXIDE; IMMUNOGLOBULIN A ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; NEUTRALIZING ANTIBODY; PLACEBO; ROTAVIRUS VACCINE; SUBUNIT VACCINE; TETANUS TOXIN; TETANUS TOXIN P2 ROTAVIRUS VP8 SUBUNIT VACCINE; UNCLASSIFIED DRUG; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOLOGICAL ADJUVANT; NS35 PROTEIN, ROTAVIRUS; RNA BINDING PROTEIN; VIRUS PROTEIN;

ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTHRALGIA; ARTICLE; BLOOD SAMPLING; CHILL; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ADSORPTION; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INJECTION SITE SWELLING; LYMPHOCYTE; MALE; MYALGIA; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ROTAVIRUS; SUPERNATANT; VIRUS STRAIN; VOMITING; ADOLESCENT; BLOOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GASTROENTERITIS; IMMUNOLOGY; INTRAMUSCULAR DRUG ADMINISTRATION; MIDDLE AGED; NORMAL HUMAN; ROTAVIRUS INFECTIONS; SERODIAGNOSIS; TREATMENT OUTCOME; YOUNG ADULT;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ALUMINUM HYDROXIDE; ANTIBODIES, NEUTRALIZING; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; GASTROENTERITIS; HEALTHY VOLUNTEERS; HUMANS; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; INJECTIONS, INTRAMUSCULAR; LYMPHOCYTES; MALE; MIDDLE AGED; NEUTRALIZATION TESTS; PLACEBOS; RNA-BINDING PROTEINS; ROTAVIRUS INFECTIONS; ROTAVIRUS VACCINES; TREATMENT OUTCOME; VACCINES, SUBUNIT; VIRAL NONSTRUCTURAL PROTEINS; YOUNG ADULT;

EID: 84937642083     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.05.024     Document Type: Article

References (32)

1. Yen C., Tate J.E., Patel M.M., Cortese M.M., Lopman B., Fleming J., et al. Rotavirus vaccines: update on global impact and future priorities. Hum Vaccines 2011, 7:1282-1290.
2. Jiang V., Jiang B., Tate J., Parashar U.D., Patel M.M. Performance of rotavirus vaccines in developed and developing countries. Hum Vaccines 2010, 6:532-542.
3. Pasetti M.F., Simon J.K., Sztein M.B., Levine M.M. Immunology of gut mucosal vaccines. Immunol Rev 2011, 239:125-148.
4. Jiang B., Gentsch J.R., Glass R.I. Inactivated rotavirus vaccines: a priority for accelerated vaccine development. Vaccine 2008, 26:6754-6758.
5. Jiang B., Gentsch J.R., Glass R.I. The role of serum antibodies in the protection against rotavirus disease: an overview. Clin Infect Dis: Off Publ Infect Dis Soc Am 2002, 34:1351-1361.
6. Westerman L.E., McClure H.M., Jiang B., Almond J.W., Glass R.I. Serum IgG mediates mucosal immunity against rotavirus infection. Proc Natl Acad Sci U S A 2005, 102:7268-7273.
7. Wang Y., Azevedo M., Saif L.J., Gentsch J.R., Glass R.I., Jiang B. Inactivated rotavirus vaccine induces protective immunity in gnotobiotic piglets. Vaccine 2010, 28:5432-5436.
8. Johansen K., Schroder U., Svensson L. Immunogenicity and protective efficacy of a formalin-inactivated rotavirus vaccine combined with lipid adjuvants. Vaccine 2003, 21:368-375.
9. Istrate C., Hinkula J., Charpilienne A., Poncet D., Cohen J., Svensson L., et al. Parenteral administration of RF 8-2/6/7 rotavirus-like particles in a one-dose regimen induce protective immunity in mice. Vaccine 2008, 26:4594-4601.
10. Angel J., Franco M.A., Greenberg H.B. Rotavirus vaccines: recent developments and future considerations. Nat Rev Microbiol 2007, 5:529-539.
11. Appaiahgari M.B., Glass R., Singh S., Taneja S., Rongsen-Chandola T., Bhandari N., et al. Transplacental rotavirus IgG interferes with immune response to live oral rotavirus vaccine ORV-116E in Indian infants. Vaccine 2014, 32:651-656.
12. Ramachandran M., Vij A., Kumar R., Das B.K., Gentsch J.R., Bhan M.K., et al. Lack of maternal antibodies to P serotypes may predispose neonates to infections with unusual rotavirus strains. Clin Diagn Lab Immunol 1998, 5:527-530.
13. Ray P.G., Kelkar S.D., Walimbe A.M., Biniwale V., Mehendale S. Rotavirus immunoglobulin levels among Indian mothers of two socio-economic groups and occurrence of rotavirus infections among their infants up to six months. J Med Virol 2007, 79:341-349.
14. * from rhesus rotavirus. Arch Virol 1995, 140:1969-1978.
15. Ward R.L., Bernstein D.I., Shukla R., Young E.C., Sherwood J.R., McNeal M.M., et al. Effects of antibody to rotavirus on protection of adults challenged with a human rotavirus. J Infect Dis 1989, 159:79-88.
16. * subunit parenteral vaccine candidates. Vaccine 2012, 30:6121-6126.
17. * subunit parenteral vaccines. Vaccine 2014, 32:4420-4427.
18. Knowlton D.R., Spector D.M., Ward R.L. Development of an improved method for measuring neutralizing antibody to rotavirus. J Virol Methods 1991, 33:127-134.
19. Chang H.S., Sack D.A. Development of a novel in vitro assay (ALS assay) for evaluation of vaccine-induced antibody secretion from circulating mucosal lymphocytes. Clin Diagn Lab Immunol 2001, 8:482-488.
20. Wilcoxon F. Individual comparisons by ranking methods. Biom Bull 1945, 1:80-83.
21. Armitage P. Tests for linear trends in proportions and frequencies. Biometrics 1955, 11:375-386.
22. Larralde G., Flores J. Identification of gene 4 alleles among human rotaviruses by polymerase chain reaction-derived probes. Virology 1990, 179:469-473.
23. WHO. Rotavirus vaccines: WHO position paper-January 2013. 2013.
24. WHO. The expanded programme on immunization 〈〉 2013 [accessed 01.04.15 and last updated 01.12.13]. http://www.who.int/immunization/programmes_systems/supply_chain/benefits_of_immunization/en/.
25. Estes M.K., Graham D.Y., Mason B.B. Proteolytic enhancement of rotavirus infectivity: molecular mechanisms. J Virol 1981, 39:879-888.
26. Panina-Bordignon P., Tan A., Termijtelen A., Demotz S., Corradin G., Lanzavecchia A. Universally immunogenic T cell epitopes: promiscuous binding to human MHC class II and promiscuous recognition by T cells. Eur J Immunol 1989, 19:2237-2242.
27. Ahlborg N., Ling I.T., Holder A.A., Riley E.M. Linkage of exogenous T-cell epitopes to the 19-kilodalton region of Plasmodium yoelii merozoite surface protein 1 (MSP1(19)) can enhance protective immunity against malaria and modulate the immunoglobulin subclass response to MSP1(19). Infect Immun 2000, 68:2102-2109.
28. Falugi F., Petracca R., Mariani M., Luzzi E., Mancianti S., Carinci V., et al. Rationally designed strings of promiscuous CD4(+) T cell epitopes provide help to Haemophilus influenzae type b oligosaccharide: a model for new conjugate vaccines. Eur J Immunol 2001, 31:3816-3824.
29. Padilla-Noriega L. Elisas for rotavirus diagnosis, typing, and analysis of antibody response. In: Abuelzein E, editor. Trends in immunolabelled and related techniques. 2012. pp. 227-42.
30. Santos N., Hoshino Y. Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev Med Virol 2005, 15:29-56.
31. Seheri M., Nemarude L., Peenze I., Netshifhefhe L., Nyaga M.M., Ngobeni H.G., et al. Update of rotavirus strains circulating in Africa from 2007 through 2011. Pediatr Infect Dis J 2014, 33(Suppl 1):S76-S84.
32. Todd S., Page N.A., Duncan Steele A., Peenze I., Cunliffe N.A. Rotavirus strain types circulating in Africa: review of studies published during 1997-2006. J Infect Dis 2010, 202(Suppl):S34-S42.