Previous Studies

Jenner Hut or Temple of Vaccinia: One of the first vaccine clinical trials occurred in May, 1796 when Edward Jenner, an English country doctor, vaccinated an 8 year old boy named James Phipps with fluid from a cowpox blister hoping to protect him from smallpox. It worked!

Vaccine studies completed by the SIVS Clinical Trials Program

(Last updated March 5, 2024)

Links to ClinicalTrials.gov provided for further information, including results in some cases.

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NCT04642079: Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age

For more information, please visit www.nexxstep14study.com
or contact Robert Cox, RN 409-772-5278 sivsctp@utmb.edu

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

For clinicaltrials.gov information, click here
NCT04525599: A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

For more information, please visit www.VaccineStudyForKids.com
or contact Robert Cox, RN 409-772-5278 or sivsctp@utmb.edu

Sponsor: Astellas Pharma Global Development Inc. (APGD)
Principal Investigator: Richard Rupp, MD

For clinicaltrials.gov information, click here
NCT04470427: A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19

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

For more information click here
NCT04368728: Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

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

For more information click here
NCT04199689: Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

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

For more information click here
NCT04144348: Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12-36 Months of Age With Serologic Evidence of Prior Exposure

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

For more information click here
NCT03893448: Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (PNEU-PED)

Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator (Galveston): Richard Rupp, MD
Principal Investigator (Bay Colony): Marcela Navarro, MD

For more information click here
NCT03738241: A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Dose of 2017 A/H7N9 Inactivated Influenza Vaccine (IIV) Administered IM With or Without AS03 Adjuvant in 2013 A/H7N9 IIV Primed or A/H7 IIV Naïve Subjects

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

For more information click here
NCT03738241: A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Dose of 2017 A/H7N9 Inactivated Influenza Vaccine (IIV) Administered IM With or Without AS03 Adjuvant in 2013 A/H7N9 IIV Primed or A/H7 IIV Naïve Subjects

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

For more information click here
NCT03692871: A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator: Marcela Navarro, MD

For more information click here
NCT03682120: A Phase II Study in Healthy Adults 18-64 Years Old to Assess the Safety, Reactogenicity and Immunogenicity of a Seqirus A/H7N9 Inactivated Influenza Vaccine Administered Intramuscularly With or Without MF59(R) Adjuvant

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

For more information click here
NCT03620162: A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

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

For more information click here
NCT03547167: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)

Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator: Richard Rupp, MD
For more information click here
NCT03537508: Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

Sponsor: Sanofi Pasteur
Principal Investigator: Richard Rupp, MD

For more information click here
NCT03524118: A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants

Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator: Richard Rupp, MD
For more information click here
NCT03512288: Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants (B747-1003)

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

For more information click here
NCT03512288: Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants (B747-1003)

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

For more information click here
NCT03486834: Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)

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

For more information click here
NCT03480763: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)

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

For more information click here
NCT03381196: A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications

Sponsor: Janssen Research & Development, LLC
Principal Investigator: Richard Rupp, MD

For more information click here
NCT03239873: 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

Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator: Richard Rupp, MD
For more information click here
NCT03207750: Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age

Sponsor: GlaxoSmithKline
Principal Investigator: Richard Rupp, MD
For more information click here
NCT03090191: A phase III, placebo-controlled, randomized, observer-blinded, study to evaluate efficacy, and tolerability of a Clostridium difficile vaccine in adults 50 years of age and older (CLOVER)

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

For more information click here
NCT03014310: H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID, Principal Investigator: Richard Rupp, MD
For more information click here
NCT02987972: A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

Sponsor: Merck Sharp & Dohme Corp

Principal Investigator (Galveston): Richard Rupp, MD
Principal Investigator (Bay Colony): Mark Wolffarth, MD

For more information click here
NCT02623322: A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults

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

For more information click here
NCT02531373: A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

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

For more information click here
NCT02503202: Merck V920-012: Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)

Sponsor: Merck, Sharp, Dohme Corp.
Principal Investigator: Richard Rupp, MD
For more information click here
NCT02242643: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age [GSK 201234 (FLU Q-QIV-022)]

Sponsor: GlaxoSmithKline
Principal Investigator: Kwabena Sarpong, MD, MPH
For more information click here
NCT02213354: H7N9 Mix and Match With MF59 in Healthy Elderly Persons (DMID 13-0034)

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

For more information click here
NCT02184572: Safety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age

Sponsor: GlaxoSmithKline
Principal Investigator: Kwabena Sarpong, MD, MPH
For more information click here
NCT02062502: A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II [Merck V210-063]

Sponsor: Merck Sharp Dohme Corp.
Principal Investigator: Richard Rupp, MD
For more information click here
NCT02037984: A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants [Merck V114-004]

Sponsor: Merck, Sharp, Dohme Corp.
Principal Investigator: Richard Rupp, MD
For more information click here
NCT01986010: 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 [Merck V160-001]

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

For more information click here
NCT01984697: A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (Merck V503-010)

Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator: Richard Rupp, MD
For more information click here
NCT01938742: H7N9 Mix and Match With MF59 in Healthy Adults (DMID 13-0032)

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

For more information click here.
NCT01765426: Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector (INV-DEN-103)

Sponsor: Takeda
Collaborator: National Institutes of Health (NIH)
Principal Investigator: Richard Rupp, MD

For more information, click here.
NCT01702428: Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age (GSK MMR 160)

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

For more information click here.
NCT01651949: Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

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

For more information click here.
NCT01542632: A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers (INV-DEN-104)

Sponsor: Takeda
Principal Investigator: Richard Rupp, MD

For more information click here.
NCT01536405: Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator: Richard Rupp, MD
For more information click here.
NCT01513551: Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

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

For more information click here.
NCT01461993: A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17

Sponsor: Pfizer
Principal Investigator: Richard Rupp, MD

For more information click here.
NCT01266850: Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules (DMID 08-017)

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

For more information, click here.
NCT01254630: A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients With Solid Tumor or Hematologic Malignancy (V212-011)

Sponsor: Merck Sharp & Dohme Corp.
Principal Investigator: Avi Markowitz, MD
For more information click here.
NCT01215188: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants (V114-003)

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

For more information click here.
NCT00976027: Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age

Sponsor: Sanofi pasteur
Principal Investigator: Alvah Cass, MD

For more information, click here.
NCT00943202: Sanofi Pasteur, TIV + H1N1, Pediatric Population (DMID 09-0047)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID
DMID
Principal Investigator: Christine Turley, MD

For more information, click here.
NCT00921947: Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults

Sponsor: VaxInnate Corporation
Principal Investigator: Christine Turley, MD

For more information click here.
NCT00912496: Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59 DMID (08-0013)

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

For more information, click here.
NCT00856297: Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine (V59P13E1)

Sponsor: Novartis Vaccines
Principal Investigator: Richard Rupp, MD

For more information, click here.
NCT00806195: Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants (V59P23)

Sponsor: Novartis
Principal Investigator: Richard Rupp, MD

For more information, click here.
NCT00761631: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

Sponsor: Wyeth/Pfizer
Principal Investigator: Richard Rupp, MD

For more information, click here.
NCT00614614: Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014

Sponsor: GlaxoSmithKline
Principal Investigator: Kwabena Sarpong, MD

For more information, click here.
NCT00603811: Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults

Sponsor: VaxInnate Corporation
Principal Investigator: Christine Turley, MD

For more information, click here.
NCT00551031: Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects (FID29)

Sponsor: Sanofi Pasteur
Principal Investigator: Richard Rupp, MD

For more information, click here.
NCT00450437: A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults (V59P13)

Sponsor: Novartis Vaccines
Principal Investigator: Richard Rupp, MD

For more information, click here.
NCT00444457: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants ( Wyeth/Pfizer 6096A1-3005)

Sponsor: Wyeth/Pfizer
Principal Investigator: Richard Rupp, MD

For more information, click here.
NCT00437021: Evaluation of IMVAMUNE® Smallpox Vaccine With Respect to Safety and Optimization of Immune Responses by Different Vaccination Regimens in Vaccinia-Naïve Adults (DMID 06-0012)

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

For more information, click here.
NCT00388583: Immunogenicity and Safety of The Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Ambulatory Elderly Subjects

Sponsor: Sanofi Pasteur
Principal Investigator: Christine Turley, MD

For more information click here
NCT00297817: A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age

Sponsor: Novartis Vaccines
Principal Investigator: Richard Rupp, MD

For more information click here
NCT00289783: Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Sponsor: GlaxoSmithKline
Principal Investigator: Christine Turley, MD

For more information click here
NCT00255047: Safety and Immune Response of Different Pediatric Combination Vaccines. (M5A10)

Sponsor: Sanofi Pasteur
Principal Investigator: Christine Turley, MD

For more information click here
NCT00224484: Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old

Sponsor: GlaxoSmithKline
Principal Investigator: Richard Rupp, MD

For more information click here
NCT00224471: Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine

Sponsor: GlaxoSmithKline
Principal Investigator: Richard Rupp, MD

For more information click here
NCT00133497: gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females -

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

For more information click here
NCT00090233: Rotavirus Efficacy and Safety Trial (REST)(V260-006):

Sponsor: Merck Sharp & Dohme Corp
Principal Investigator: Janak Patel, MD

For more information click here
Merck V181-001: A Phase 1 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

Sponsor: Merck Sharp & Dohme Corp
Principal Investigator: Richard Rupp, MD
Merck V016-01 A Study to Demonstrate Immunogenicity and Tolerability of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Pre-Adolescents and Adolescents, and to Determine End-Expiry Specifications for the Vaccine

Sponsor: Merck Sharp & Dohme Corp
Principal Investigator: Richard Rupp, MD
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Lyophilized Formulation of BNT162b2 Against COVID-19 in Healthy Adults

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

For more information click here