Clinical trials: Smallpox
Smallpox
A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects.
- Trial name
- NCT00316524
- Testing
- MVA-BN® (IMVAMUNE)
- Where
- Germany
- Volunteers
- 745 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Smallpox
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
- Trial name
- NCT00053482
- Testing
- ACAM2000 Smallpox Vaccine, Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
- Where
- 3 sites in United States
- Volunteers
- 357 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Smallpox, Mpox
A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age
The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769 in healthy adult participants.
- Trial name
- NCT05995275
- Testing
- mRNA-1769
- Where
- 12 sites in United Kingdom
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Neonate, Maternal Transmission
Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC
This Phase 3 open-label study aims to assess the safety and immune response of the MVA-BN mpox vaccine when administered subcutaneously to pregnant and postpartum women in the Democratic Republic of the Congo (DRC), a population…
- Conditions
- Neonate, Maternal Transmission, Mpox, Vaccination
- Trial name
- PregInPoxVac (NCT06844500)
- Testing
- MVA-BN standard regimen, MVA-BN standard regimen (Administered as PEP)
- Where
- Democratic Republic of the Congo
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- Jean-Pierre Van geertruyden
Smallpox, Monkeypox
Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years
The Aim: Study immunogenicity, confirm the safety and tolerability of different schedules of vaccination with "live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus"…
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05846243
- Testing
- VAC∆6 vaccine (10⁷ PFU), VAC∆6 vaccine (10⁶ PFU), Live Smallpox Vaccine
- Where
- 2 sites in Russia
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Smallpox, Monkeypox
Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years
The aim of the clinical study is to study the safety and tolerability of the live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus, in intracutaneous administration.
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05762523
- Testing
- VAC∆6 vaccine - оnce at a dose of 10⁶ PFU, VAC∆6 vaccine - once at a dose of 10⁷ PFU, VAC∆6 vaccine - twice at a dose of 10⁶ PFU
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Monkeypox
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
- Trial name
- SMART (NCT05745987)
- Testing
- Bavarian Nordic smallpox vaccine, Typhoid VI Polysaccharide Vaccine Injectable Solution
- Where
- 10 sites in Democratic Republic of the Congo, Nigeria and 1 more
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- McMaster University
HIV Infections
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations
- Trial name
- NCT00316589
- Testing
- IMVAMUNE (MVA-BN)
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 581 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Orthopoxviral Disease, Smallpox
Phase I Trial of an Investigational Small Pox Medication
The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.
- Conditions
- Orthopoxviral Disease, Smallpox, Monkey Pox
- Trial name
- NCT00728689
- Testing
- ST-246 Days 1 - 3, ST-246 Days 11 - 13
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Smallpox
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days
This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects.
- Trial name
- NCT04971109
- Testing
- TPOXX
- Where
- 9 sites in United States
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Smallpox, Monkeypox
Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years
The Aim: To study safety, tolerability and pharmacokinetics of NIOCH-14 when administered orally using a set of clinical and laboratory-instrumental methods.
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05976100
- Testing
- NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally, NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day), NIOCH-14, 200 mg capsule: 6 capsules (200 mg each) of NIOCH-14 per day orally. (Total 1200 mg NIOCH-14 per day)
- Where
- Russia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Smallpox
MVA Post-Event: Administration Timing and Boost Study
The purpose of this study is to evaluate an investigational smallpox vaccine, called IMVAMUNE®, with respect to safety and immune (body's defense system) response.
- Trial name
- NCT00437021
- Testing
- Live vaccinia virus vaccine, MVA Smallpox Vaccine
- Where
- 7 sites in United States
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox
Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®
This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion.
- Trial name
- NCT00042094
- Testing
- Cell-Cultured Smallpox Vaccine compared to Dryvax®
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Smallpox
A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects
A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects
- Trial name
- NCT01668537
- Testing
- LF formulation of IMVAMUNE®, FD formulation of IMVAMUNE®
- Where
- 3 sites in United States
- Volunteers
- 651 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Monkeypox Virus Infection
JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo
Mpox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus infections that can prevent them from performing work…
- Trial name
- NCT02977715
- Testing
- JYNNEOS (Liquid Formulation), JYNNEOS (Lyophilized Formulation)
- Where
- Democratic Republic of the Congo
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention