Clinical trials: Controlled Human Infection
Influenza
Assessment of CR8020, a Monoclonal Antibody Against Influenza A Viruses
The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal antibody against influenza A viruses.
- Trial name
- NCT01756950
- Testing
- 2 mg/kg CR8020, 5 mg/kg CR8020, 15 mg/kg CR8020
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Hepatitis B, Infectious Disease
A Study in Healthy Volunteers
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers.
- Conditions
- Hepatitis B, Infectious Disease, Liver Diseases
- Trial name
- NCT03596697
- Testing
- CRV431, TDF
- Where
- 3 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Influenza
H5N1 Mix and Match With MF59
Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study.
- Trial name
- NCT01317745
- Testing
- Phosphate Buffered Saline (PBS) diluent, MF59 Adjuvant, H5N1 Antigen
- Where
- 5 sites in United States
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Sexually Transmitted Infections
Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women
The purpose of this program evaluation is to determine whether the Health Love Workshop, a group-level HIV behavioral intervention, reduces HIV-related sex risk behaviors and increases HIV protective behaviors of African American…
- Trial name
- NCT00362375
- Testing
- Healthy Love Workshop, HIV/AIDS 101 Workshop
- Where
- United States
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Influenza
Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above
Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)
- Trial name
- NCT00620815
- Testing
- Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine, Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine
- Where
- 2 sites in Germany
- Volunteers
- 601 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV Infections
Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
The purpose of this study is to find out whether these powerful combinations of anti-HIV drugs are safe and effective for use in patients in the early stages of HIV infection and to find out how patients' immune systems react to…
- Trial name
- NCT00001119
- Testing
- Tetanus Toxoid Vaccine, Indinavir sulfate, Lamivudine/Zidovudine
- Where
- 12 sites in United States, Australia
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Shigella, Diarrhea
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
- Trial name
- NCT07205926
- Testing
- IVT Shigella-04
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Malaria, Falciparum
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
- Trial name
- NCT06171113
- Testing
- GSK4024484C
- Where
- United Kingdom
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Hepatitis B
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
- Conditions
- Diphtheria, Hepatitis B, Whole Cell Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00317135
- Testing
- Tritanrix-HepB/Meningitec conjugate vaccine, Tritanrix/Hiberix vaccine
- Where
- Philippines
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004
The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.
- Trial name
- NCT00161837
- Testing
- Vero Cell-derived Influenza Vaccine, Egg-derived Influenza Vaccine
- Where
- Poland
- Volunteers
- healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
HIV Infections
First Time in Human Study of Long Acting VH4524184 Formulations
The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the…
- Trial name
- NCT06310551
- Testing
- Oral VH4524184, VH4524184 Formulation A SC, rHuPH20
- Where
- 3 sites in United States
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Influenza
A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers
This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose study of the safety and priming potential of an intramuscular Influenza vaccine (Multimeric-001) injected to elderly volunteers.
- Trial name
- NCT01010737
- Testing
- Multimeric-001 250 mcg, Adjuvanted Multimeric-001 250mcg, Adjuvant: Montonide isa 51 VG
- Where
- Israel
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- BiondVax Pharmaceuticals ltd.
Influenza
Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine
This Phase 1/2 study is intended to assess the safety, tolerability, and immunogenicity of recombinant TVLP in adults 18-64 and 65 years of age and above and to confirm the dose(s) to be developed further in these two age cohorts.
- Trial name
- NCT07291635
- Testing
- Recombinant Influenza vaccine candidate, Commercial Influenza vaccine
- Where
- 7 sites in Canada
- Volunteers
- 728 people, healthy volunteers welcome
- Sponsor
- Aramis Biotechnologies Inc.
Seasonal Influenza
A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase…
- Trial name
- NCT06602024
- Testing
- mRNA-1010, Fluarix®, Influsplit® Tetra
- Where
- 301 sites in United States, Belgium and 9 more
- Volunteers
- 40,805 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Influenza A
Safety, Tolerability, Efficacy and Immunogenicity of an Influenza A Vaccine (FP-01.1) in Healthy Volunteers Following Virus Challenge
The purpose of this study is to assess the safety, tolerability, efficacy, and immunogenicity of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in healthy volunteers following a dose of influenza A virus.
- Trial name
- NCT02071329
- Testing
- Vaccine FP-01.1, Virus Challenge
- Where
- United Kingdom
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Immune Targeting Systems Ltd
Infections, Rotavirus
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam.
- Trial name
- NCT00345956
- Testing
- Human rotavirus liquid vaccine
- Where
- 2 sites in Vietnam
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B Vaccines
Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C:An Open-label Control Study in China
Background Hepatitis B virus (HBV) co-infection in individuals with hepatitis C virus (HCV) can enhance the severity of hepatitis and the risks of liver cirrhosis and hepatocellular carcinoma (HCC).
- Trial name
- NCT02898922
- Testing
- hepatitis B vaccine made by Recombinant DNA Techniques in Saccharomyces Cerevisiae
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Shandong Province Centers for Disease Control and Prevention
HIV Infections
A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus
To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for health care workers at risk for HIV infection from exposure to HIV-contaminated blood or blood components.
- Trial name
- NCT00002287
- Testing
- Zidovudine
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Glaxo Wellcome
Upper Respiratory Disease, Influenza
Immune Defense Protein Impact On Respiratory Immune Outcomes
The primary goal of this study is to observe the impact of the IDP® Supplement on the duration and severity of upper respiratory symptoms in older individuals during the cold and flu season.
- Conditions
- Upper Respiratory Disease, Influenza, Viral Upper Respiratory Infection
- Trial name
- NCT07431840
- Testing
- Immune Defense Protein 50mg Dose, IDP 200mg Dose
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Quantec Ltd
Malaria
Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults
The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system.
- Trial name
- NCT02174978
- Testing
- FMP012 with AS01B adjuvant system, P falciparum Controlled Human Malaria Infection (CHMI)
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command