Current Studies

 

Studies currently being conducted by the SCVD Clinical Trials Program

Last updated January 24, 2018

Click on the ClinicalTrials.gov Identifier (NCT number) for more information.

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NCT00000000 - Currently recruiting!

A Phase I Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Live-Attenuated Tetravalent Dengue Vaccine (V181) in Flavivirus-Naïve and Flavivirus-Experienced Healthy Adults

This study will evaluate the the overall safety and tolerability of the tested V181 formulations.

Sponsor: Merck Sharp & Dohme Corp.; Principal Investigator: Richard Rupp, MD


NCT03239873 - Currently recruiting!

A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX Passage Extension 34 (PE34) Process Administered Concomitantly with M-M-R II

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX 2016 commercial process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX PE34 Process are non-inferior to those induced by VARIVAX 2016 commercial process, and that antibody response rate induced by VARIVAX PE34 Process is acceptable.

Sponsor: Merck Sharp & Dohme Corp.; Principal Investigator: Richard Rupp, MD


NCT03207750 - Currently recruiting!

A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13 when co-administered with two doses of the PCV-free liquid formulation of GSK Biologicals’ oral live attenuated HRV vaccine as compared to the currently licensed lyophilized formulation of the HRV vaccine in healthy infants 6-12 weeks of age.

Purpose: This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix, Hiberix and Prevenar 13 When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine

Sponsor: GlaxoSmithKline Principal Investigator: Richard Rupp, MD


NCT03090191 - Currently recruiting!

A Phase 3, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Efficacy, Safety, And Tolerability Of A Clostridium Difficile Vaccine In Adults 50 Years Of Age And OlderPurpose: The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection

Sponsor: Pfizer Principal Investigator: Richard Rupp, MD


 

NCT02987972 - Active, not recruiting

V114-008: A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13 in Healthy Infants

Purpose:This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13.

Sponsor: Merck Sharp & Dohme Corp.

Principal Investigator: Richard Rupp, MD, Pediatric Clinic, Galveston Island East

Principal Investigator: Mark Wolffarth, MD, Pediatric Clinic, League City (Bay Colony)


 

NCT02624947 - Active, not recruiting

A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal ImmunizationPurpose: To determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia through the first 90 days of life in infants.

Sponsor: Novavax Principal Investigator: George Saade, MD


 

NCT03014310 - Active, not recruiting

A Phase I Cohort-Randomized, Double-Blind, Controlled Trial in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of a Monovalent Inactivated Influenza A/H5N8 Virus Vaccine Administered Intramuscularly at Different Dosages Given With or Without AS03 or MF59 Adjuvants: Assessment of Immunological Responses and Lymphocyte Interplay

Purpose: This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Principal Investigator: Richard Rupp, MD


 

Last updated January 24, 2017

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