Current Studies

Studies currently being conducted by the SCVD Clinical Trials Group

Last updated June 17, 2016

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

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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


NCT02037984 - Ongoing but not recruiting

V114-004: A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity 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


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


NCT02184572 - Ongoing but not recruiting

Safety and Immunogenicity Study of GSK Biologicals' MMR Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age

Purpose: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age

Sponsor: GlaxoSmithKline; Principal Investigator: Kwabena Sarpong, MD, MPH


NCT02213354 - Ongoing but not recruiting

H7N9 Mix and Match With MF59 in Healthy Elderly Persons

A Phase II Randomized, Partially-Blinded, Controlled Trial in Healthy Adults Aged 65 Years and Older to Assess the Safety, Reactogenicity, and Immunogenicity of an MF59-Adjuvanted, Monovalent Inactivated Influenza A/H7N9 Virus Vaccine Administered Intramuscularly at Different Intervals and Dosages

Purpose: This is a Phase II randomized, partially-blinded, controlled study in up to 600 healthy elderly persons, aged 65 years and older, designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine administered at different dosages and intervals given with and without MF59 adjuvant. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2.

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


NCT02184572 - Ongoing but not recruiting

115648 (MMR-160): A phase IIIA, randomized, observer-blind, controlled, multinational consistency study to evaluate the immunogenicity and safety of GSK Biologicals' MMR vaccine (209762) (Priorix) compared to Merck & Co., Inc.’s MMR vaccine (M-M-R II), as a first dose, both co-administered with Varivax, Havrix and Prevnar 13 (subset of children) to healthy children 12 to 15 months of age.

Sponsor: GlaxoSmithKline; Principal Investigator: Kwabena Sarpong, MD, MPH


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 June 17, 2016