Abstract

The contractor serves as a general Vaccine and Treatment Evaluation Unit for the Enteric Diseases Branch, DMID, NIAID. Phase I and II clinical studies will be performed in adult (including elderly), adolescent, and pediatric groups consisting of normal and """"""""at risk"""""""" individuals. Responses to vaccines including combinations, new adjuvants, live vectors as well as antivirals and other prophylactic and therapeutic interventions will be studied. Safety, immune responses, correlates of immunity will be analyzed. Examples of vaccines to be studied include, but are not limited to: rotavirus, hepatitis A, Herpes simplex type II, influenza, Bordetella pertussis, Haemophilus influenzae type B, Neisseria meningitidis, Streptococcus pneumonia, and Group B streptococci, respiratory syncytial virus, and parainfluenza virus. In addition to clinical trials, limited epidemiologic surveillance studies will be performed to determine the presence of infectious disease agents and the disease caused by them to help in the design of prevention studies and to understand infection/disease. There is a possibility that Phase III studies will be initiated if the attack rate warrants a study at this site. Multicenter trials involving one or more of the other Vaccine and Treatment Evaluation Units may be initiated as well.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research and Development Contracts (N01)
Project #
N01AI025135-003
Application #
2295415
Study Section
Project Start
1991-12-20
Project End
1996-12-19
Budget Start
1992-11-30
Budget End
1993-12-19
Support Year
Fiscal Year
1993
Total Cost
Indirect Cost

  Institution

Name
Baylor College of Medicine
Department
Microbiology/Immun/Virology
Type
Schools of Medicine
DUNS #
074615394
City
Houston
State
TX
Country
United States
Zip Code
77030

  Publications

Bernstein, David I; Yan, Lihan; Treanor, John et al. (2003) Effect of yearly vaccinations with live, attenuated, cold-adapted, trivalent, intranasal influenza vaccines on antibody responses in children. Pediatr Infect Dis J 22:28-34
Lee, Edwin A M; Palmer, Dupeh R; Flanagan, Katie L et al. (2002) Induction of T helper type 1 and 2 responses to 19-kilodalton merozoite surface protein 1 in vaccinated healthy volunteers and adults naturally exposed to malaria. Infect Immun 70:1417-21
Piedra, Pedro A; Yan, Lihan; Kotloff, Karen et al. (2002) Safety of the trivalent, cold-adapted influenza vaccine in preschool-aged children. Pediatrics 110:662-72
Keitel, Wendy A (2002) Repeated immunization of children with inactivated and live attenuated influenza virus vaccines: safety, immunogenicity, and protective efficacy. Semin Pediatr Infect Dis 13:112-9
Weingart, C L; Keitel, W A; Edwards, K M et al. (2000) Characterization of bactericidal immune responses following vaccination with acellular pertussis vaccines in adults. Infect Immun 68:7175-9
Keitel, W A; Kester, K E; Atmar, R L et al. (1999) Phase I trial of two recombinant vaccines containing the 19kd carboxy terminal fragment of Plasmodium falciparum merozoite surface protein 1 (msp-1(19)) and T helper epitopes of tetanus toxoid. Vaccine 18:531-9
Keitel, W A; Muenz, L R; Decker, M D et al. (1999) A randomized clinical trial of acellular pertussis vaccines in healthy adults: dose-response comparisons of 5 vaccines and implications for booster immunization. J Infect Dis 180:397-403
Englund, J A; Glezen, W P; Thompson, C et al. (1997) Haemophilus influenzae type b-specific antibody in infants after maternal immunization. Pediatr Infect Dis J 16:1122-30
Keitel, W A; Edwards, K M (1995) Pertussis in adolescents and adults: time to reimmunize? Semin Respir Infect 10:51-7
Meade, B D; Deforest, A; Edwards, K M et al. (1995) Description and evaluation of serologic assays used in a multicenter trial of acellular pertussis vaccines. Pediatrics 96:570-5

Showing the most recent 10 out of 19 publications