Current Studies

Studies currently being conducted by the SCVD Clinical Trials Group

Last updated May 15, 2017

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

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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 Older

Purpose: 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


NCT02623322 - Currently recruiting in two locations!

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 - Currently recruiting!

A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization

Purpose: 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


NCT02623322 - Currently Recruiting!

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, Administered as Monotherapy for the Treatment of Acute Uncomplicated Seasonal Influenza A Infection in Otherwise Healthy Adults

Purpose: This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.

Sponsor: Genentech, Inc. Principal Investigator: Richard Rupp, MD


NCT 03014310 Ongoing but 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


NCT02531373 - Ongoing but not recruiting

V114-005: A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

Purpose: This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

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


NCT02503202 - Ongoing but not recruiting

V920-012: A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults

Purpose: The study will evaluate the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study is to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 (at release dose) through 28 days postvaccination. Safety will be evaluated for all participants through 6 months postvaccination.

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


 

NCT01986010 - Ongoing but not recruiting

Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults

Purpose: This study will evaluate the safety, tolerability, and immunogenicity of various doses, formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160 administered in a 3-dose regimen in healthy adults. Each treatment arm of 10 participants will be accompanied by a placebo arm of 4 participants. The initial treatment arm of HCMV seropositive participants will receive V160 Low Dose without adjuvant by intramuscular injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal injection, and vaccination of HCMV seronegative participants will be performed only after review of safety data of previous treatment arms. The purpose of the study is to identify vaccine formulations associated with optimal safety profile and HCMV-specific immune response for evaluation in subsequent clinical studies of V160

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


 

NCT01984697 - Ongoing but not recruiting

V503-010: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women Protocol.

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


 

NCT01254630 - Ongoing but not recruiting

A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)

Sponsor: Merck Sharp & Dohme Corp.; Principal Investigator: Avi Markowitz, MD


 

Last updated May 15, 2017