Phase 2
Completed N=260
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Dengue Fever · Dengue Hemorrhagic Fever · Dengue
Source: ClinicalTrials.gov NCT00617344 ↗
Enrolled (actual)
260
Serious AEs
2.8%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation — 1.0; 3.0; 65.4; 81.0 percentage of participants
Summary
This study used 3 different formulations of tetravalent CYD dengue vaccine.
The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6.
The secondary objectives were:
* To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine.
* To describe the neutralizing antibody responses to each of the 3 vaccine formulations.
* To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation |
1.0; 3.0; 65.4; 81.0; 1.0; 3.0 | — |
| SECONDARY Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain |
1.0; 3.0; 3.8; 33.7; 50.5; 26.4 | — |
| SECONDARY Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes |
16.8; 20.8; 17.0; 96.0; 93.1; 98.1 | — |
| SECONDARY Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain |
5.04; 5.57; 5.23; 9.97; 20.3; 9.29 | — |
| SECONDARY Number of Participants With Solicited Injection Site Reactions After Any Vaccination |
50; 42; 15; 46; 35; 15 | — |
| SECONDARY Number of Participants With Solicited Systemic Reactions After Any Vaccination |
14; 20; 6; 11; 18; 3 | — |
| SECONDARY Number of Participants With Vaccine Viremia |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy, as determined by medical history, clinical examination, and biological safety parameters.
- Aged 18 to 45 years on the day of inclusion.
- Provision of informed consent signed by the participant or another legally acceptable representative.
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination.
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test.
- Breast-feeding woman.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids were allowed.
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
- Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations.
- Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C virus seropositivity in blood sample taken at Screening.
- Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at Screening.
- Previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity.
- Reported history of flavivirus infection as reported by the participant.
- Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).
- Flavivirus vaccination planned during the trial period.
Data sourced from ClinicalTrials.gov (NCT00617344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.