MVA Post-Event: Administration Timing and Boost Study
Smallpox
Bottom Line
View on ClinicalTrials.gov: NCT00437021 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Live vaccinia virus vaccine (Biological); MVA Smallpox Vaccine (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Bavarian Nordic's (BN) Plaque Reduction Neutralizing Antibody Titer (PRNT) Assay in Groups A and B |
10.8; 30.2 | — |
| PRIMARY GMT of Saint Louis University's (SLU) PRNT Assay in Group A and Group B |
27.4; 212.2 | — |
| PRIMARY Frequency of Serious Adverse Events (SAEs) |
1; 2; 0; 0; 0; 3 | — |
| PRIMARY Frequency of Non-Serious AEs |
32; 43; 4; 1; 0; 26 | — |
| PRIMARY Frequency of Local Solicited Reactogenicity AEs for Groups A, B, and D and Placebo A, B, and D |
47; 50; 4; 1; 2; 0 | — |
| PRIMARY Frequency of Local Solicited Reactogenicity AEs for Groups C and F and Placebo F |
8; 50; 1 | — |
| PRIMARY Frequency of Local Solicited Reactogenicity AEs for Group E and Placebo E |
1; 0; 2; 2 | — |
| PRIMARY Frequency of Systemic Solicited Reactogenicity AEs for Groups A, B, and D and Placebo A, B, and D |
31; 41; 2; 4; 3; 0 | — |
| PRIMARY Frequency of Systemic Solicited Reactogenicity AEs for Groups C, E, and F and Placebo E and F |
5; 2; 33; 1; 3 | — |
| SECONDARY GMT of BN Enzyme Linked Immunosorbent Assay (ELISA) in Groups A and B |
108.7; 501.7 | — |
| SECONDARY GMT of SLU ELISA in Groups A and B |
60.5; 510.9 | — |
Summary
Eligibility Criteria
Inclusion Criteria
-At least 18 years of age and born after 1971 -Never received smallpox vaccination -Read, signed, and dated informed consent document -Available for follow-up for the planned duration of the study (one year after last immunization) -Acceptable medical history by screening evaluation and limited physical assessment -If the subject is female and of childbearing potential, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination -If the subject is female and of childbearing potential, she agrees to use acceptable contraception, and not become pregnant for the duration of the study a. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized b. Acceptable contraception methods are restricted to effective devices (e.g., Intrauterine Devices (IUD)s, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, and abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus) c. Women who are not sexually active must agree to use one of the acceptable contraception methods if they are of childbearing potential -Negative enzyme linked immunosorbent assay (ELISA) for human immunodeficiency virus (HIV) -Alanine aminotransferase (ALT) 140 mm Hg) or are on antihypertensive medication, and/or c. have a family history of coronary heart disease in male first-degree relative (father or brother) <55 years of age or a female first-degree relative (mother or sister) <65 years of age. -Current use of immunosuppressive medication a. Corticosteroid nasal sprays are permissible b. Persons who are using a topical steroid can be enrolled after their therapy is completed c. Inhaled steroids for asthma are not permissible -Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol -Any history of illegal injection drug use -Receipt of inactivated vaccine 14 days prior to vaccination -Receipt of live attenuated vaccine within 30 days prior to vaccination -Use of experimental agent within 30 days prior to vaccination -Receipt of blood products or immunoglobulin within six months prior to vaccination -Donation of a unit of blood within 56 days prior to vaccination or for the duration of the study -Acute febrile illness (greater than or equal to 100.5 degrees F) on the day of vaccination -Pregnant or lactating women -Eczema of any degree or history of eczema -People with atopic dermatitis, chronic exfoliative skin disorders/conditions, current Varicella zoster, or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2×2 cm -Any condition that, in the opinion of the investigator, might interfere with study objectives -Known allergy to IMVAMUNE® vaccine -Known allergy to egg or aminoglycoside -Study personnel
Data sourced from ClinicalTrials.gov (NCT00437021). 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.