Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)
Study Details
Study Description
Brief Summary
The primary hypothesis is that concomitant administration of the first doses of a 2-dose regimen of 9vHPV vaccine and 2-dose regimen of mRNA-1273 vaccine induces noninferior geometric mean titers (GMTs) of antibodies to each of the 9vHPV vaccine types at 4 weeks postdose 2 of 9vHPV vaccine AND noninferior geometric mean concentrations (GMCs) of SARS-CoV-2 spike protein-specific binding antibody at 4 weeks Postdose 2 of mRNA-1273 vaccine, compared with the corresponding postdose 2 GMTs/GMCs induced by a 2-dose regimen of 9vHPV vaccine and mRNA-1273 vaccine, where the first doses of each are administered nonconcomitantly.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Concomitant Group Participants will receive the first dose of 9vHPV vaccine and first dose of mRNA-1273 vaccine on Day 1; participants will then receive the second dose of mRNA-1273 vaccine at Month 1 and the second dose of 9vHPV vaccine at Month 6. |
Biological: 9vHPV Vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection
Other Names:
Biological: mRNA-1273 Vaccine
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Other Names:
|
| Experimental: Non-concomitant Group Participants will receive the first and second doses of mRNA-1273 vaccine on Day 1 and at Month 1, respectively; participants will then receive the first and second doses of 9vHPV vaccine at Months 2 and 8, respectively. |
Biological: 9vHPV Vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection
Other Names:
Biological: mRNA-1273 Vaccine
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 [4 weeks post vaccination 2]
Serum antibodies to human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured with a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.
- Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies [4 weeks post vaccination 2]
Serum antibodies to SARS-CoV-2 spike protein measured by electrochemiluminescence (ECL)
- Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event [Up to Day 7 post vaccination]
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined local (at the injection site) for which the participant is specifically questioned, and which are noted by the participant in their vaccine report card (VRC).
- Percentage of Participants with at Least 1 Solicited Systemic AE [Up to Day 7 post vaccination]
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined systemic events for which the participant is specifically questioned, and which are noted by the participant in their VRC.
- Percentage of Participants with at Least 1 Serious Adverse Event [Up to ~Month 9]
A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention.
- Percentage of Participants with at Least 1 Vaccine-Related SAE [Up to ~Month 9]
An SAE is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is a vaccine-related SAE.
Secondary Outcome Measures
- Percentage of Participants Who Seroconvert to Each of the 9vHPV Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Following Administration of a 2-Dose Regimen of 9vHPV Vaccine [4 weeks post vaccination 2]
Serum antibodies to human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured with a competitive luminex immunoassay (cLIA). Percentage of participants who seroconverted will be assessed.
- Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine [4 weeks post vaccination 2]
Serum antibodies to SARS-CoV-2 spike protein measured by ECL assay. Percentage of participants who experience seroresponse will be assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has not yet had coitarche and does not plan on becoming sexually active during the vaccination period
-
Participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (eVRC).
Exclusion Criteria:
-
Known allergy to any vaccine component
-
History of severe allergic reaction that required medical intervention
-
Thrombocytopenia or any coagulation disorder
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Has a history of myocarditis or pericarditis
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Has a history of a clinical or microbiological diagnosis of COVID-19 ≤90 days prior to Day 1 visit or history of multisystem inflammatory syndrome in children (MIS-C) at any time prior to Day 1 visit
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Females only: participant is pregnant
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Currently immunocompromised, or been diagnosed with immunodeficiency
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Had a splenectomy
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Receiving or has received immunosuppressive therapies within the last year
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Received any immunoglobulin product or blood-derived product within 3 months
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Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cognitive Clinical Trials, LLC ( Site 0054) | Phoenix | Arizona | United States | 85044 |
| 2 | Eclipse Clinical Research ( Site 0095) | Tucson | Arizona | United States | 85745 |
| 3 | Children's Clinic of Jonesboro, PA ( Site 0044) | Jonesboro | Arkansas | United States | 72401 |
| 4 | Preferred Research Partners Inc. ( Site 0092) | Little Rock | Arkansas | United States | 72211 |
| 5 | Coast Clinical Research, LLC ( Site 0027) | Bellflower | California | United States | 90706 |
| 6 | Ark Clinical Research ( Site 0098) | Long Beach | California | United States | 90806 |
| 7 | Valley Clinical Trials Inc. ( Site 0004) | Northridge | California | United States | 91325 |
| 8 | Medical Center for Clinical Research ( Site 0051) | San Diego | California | United States | 92120 |
| 9 | Ark Clinical Research ( Site 0108) | Tustin | California | United States | 92780 |
| 10 | Emerson Clinical Research Institute ( Site 0021) | Washington | District of Columbia | United States | 20011 |
| 11 | Accel Research Sites-DeLand Clinical Research Unit ( Site 0066) | DeLand | Florida | United States | 32720 |
| 12 | Advanced Research for Health Improvement, LLC ( Site 0012) | Immokalee | Florida | United States | 34142 |
| 13 | Acevedo Clinical Research Associates ( Site 0001) | Miami | Florida | United States | 33142 |
| 14 | Alpha Science Research ( Site 0067) | Miami | Florida | United States | 33186 |
| 15 | Advanced Research For Health Improvement LLC ( Site 0075) | Naples | Florida | United States | 34102 |
| 16 | Comprehensive Clinical Research ( Site 0038) | West Palm Beach | Florida | United States | 33409 |
| 17 | Atlanta Center for Medical Research ( Site 0055) | Atlanta | Georgia | United States | 30331 |
| 18 | Mount Vernon Clinical Research ( Site 0053) | Sandy Springs | Georgia | United States | 30328 |
| 19 | Clinical Research Prime ( Site 0088) | Idaho Falls | Idaho | United States | 83404 |
| 20 | CBH Health ( Site 0019) | Gaithersburg | Maryland | United States | 20877 |
| 21 | Quinn Healthcare/Skycrng ( Site 0084) | Ridgeland | Mississippi | United States | 39157 |
| 22 | Midwest Children's Health Research Institute ( Site 0003) | Lincoln | Nebraska | United States | 68505 |
| 23 | Certified Research Associates ( Site 0090) | Cortland | New York | United States | 13045 |
| 24 | Corning Center for Clinical Research ( Site 0091) | Horseheads | New York | United States | 14845 |
| 25 | Carolina Institute for Clinical Research, LLC ( Site 0042) | Fayetteville | North Carolina | United States | 28303 |
| 26 | M3 Wake Research, Inc. ( Site 0014) | Raleigh | North Carolina | United States | 27612 |
| 27 | Dayton Clinical Research ( Site 0028) | Dayton | Ohio | United States | 45409 |
| 28 | Thomas Jefferson University - Family and Community Medicine ( Site 0006) | Philadelphia | Pennsylvania | United States | 19107 |
| 29 | WR-ClinSearch ( Site 0049) | Chattanooga | Tennessee | United States | 37421 |
| 30 | DermResearch, Inc. ( Site 0056) | Austin | Texas | United States | 78759 |
| 31 | South Texas Clinical Research ( Site 0024) | Corpus Christi | Texas | United States | 78413 |
| 32 | South Texas Pediatric Research Group ( Site 0094) | Del Rio | Texas | United States | 78840 |
| 33 | West Houston Clinical Research Services ( Site 0078) | Houston | Texas | United States | 77055 |
| 34 | Next Level Urgent Care, LLC ( Site 0099) | Houston | Texas | United States | 77057 |
| 35 | Milton Haber, M.D. ( Site 0069) | Laredo | Texas | United States | 78041 |
| 36 | University of Texas Medical Branch ( Site 0026) | League City | Texas | United States | 77573 |
| 37 | University of Utah ( Site 0076) | Salt Lake City | Utah | United States | 84132 |
| 38 | Velocity Clinical Research, Salt Lake City ( Site 0025) | West Jordan | Utah | United States | 84088 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V503-076
- 2021-003591-13