Clinical trials: Infection Prevention
Prevention of the Meningococcal Disease
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.
The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
- Trial name
- NCT01911221
- Testing
- rMenB+OMV NZ
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV Infections, Drug Use
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
The purpose of this study is to determine the efficacy of using a mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services - particularly medication for opioid use disorder (MOUD) and…
- Conditions
- HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
- Trial name
- INTEGRA (NCT04804072)
- Testing
- Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing, HIV treatment for participants living with HIV not already in care
- Where
- 5 sites in United States
- Volunteers
- 447 people
- Sponsor
- HIV Prevention Trials Network
Meningococcal Disease
Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants
To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
- Trial name
- NCT00433914
- Testing
- rMenB, rMenB+OMV
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Human Immunodeficiency Virus
Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
The two original objectives were to determine in HIV-infected children initiating antiretroviral therapy (ART): 1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of disease progression or death as…
- Trial name
- ARROW (NCT02028676)
- Testing
- Clinically Driven Monitoring (CDM), Laboratory plus Clinical Monitoring (LCM), Arm A: ABC+3TC+NNRTI
- Where
- 4 sites in Uganda, Zimbabwe
- Volunteers
- 1,206 people
- Sponsor
- Medical Research Council
Meningococcal Infections
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
- Trial name
- NCT00616421
- Testing
- MenACWY-CRM, Licensed meningococcal ACWY vaccine
- Where
- 68 sites in United States, Canada
- Volunteers
- 2,907 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infection
Community Central Line Infection Prevention Trial
The overall goal of this Community Central Line Infection Prevention (CCLIP) trial, supported by grant R01 HS022870 from the Agency for Healthcare Research and Quality, is to determine whether use of a promising new intervention…
- Trial name
- CCLIP (NCT02351258)
- Testing
- 70% Isopropyl alcohol embedded caps, Usual Care
- Where
- 16 sites in United States
- Volunteers
- 16 people
- Sponsor
- Johns Hopkins University
Rabies
Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies
This is a Phase 2b, double blinded, randomized study of SYN023 compared to HyperRab® (a licensed Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP).
- Trial name
- ARPEP (NCT03961555)
- Testing
- SYN023, HRIG (HyperRab), Rabies vaccine
- Where
- 14 sites in United States, Philippines
- Volunteers
- 448 people
- Sponsor
- Synermore Biologics Co., Ltd.
Risk Behavior, HIV/AIDS
Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and…
- Conditions
- Risk Behavior, HIV/AIDS, Medication Adherence, Substance Abuse
- Trial name
- CHRP-BB (NCT03282890)
- Testing
- CHRP-BB
- Where
- United States
- Volunteers
- 237 people
- Sponsor
- University of Connecticut
HIV Infections, Sexually Transmitted Diseases
Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South
The goal of this study is to adapt evidence-based curriculum on HIV epidemiology and PrEP prescription to train family medicine physician trainees to take a thorough sexual history and discuss HIV/STI prevention and PrEP options…
- Trial name
- PrEP Pro (NCT06487390)
- Testing
- PrEP Pro training intervention
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Alabama at Birmingham
HIV Infections, HIV/AIDS
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP).
- Conditions
- HIV Infections, HIV/AIDS, Neisseria Gonorrheae Infection, Chlamydia Trachomatis Infection
- Trial name
- dPEP-KE (NCT04050540)
- Testing
- Doxycycline
- Where
- Kenya
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- University of Washington
Coronavirus Infection
NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19.
- Trial name
- NCT04442230
- Testing
- NasoVAX
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Altimmune, Inc.
Healthy Participants
Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Children are particularly vulnerable to respiratory virus infections, especially influenza. Vitamin A \& D deficiencies are associated with vulnerability to infectious diseases of the respiratory tract.
- Trial name
- NCT02649192
- Testing
- Influenza virus vaccine, Vitamins A and D
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- St. Jude Children's Research Hospital
Influenza
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
Influenza causes epidemics of respiratory infection in young children each winter. Young children, particularly those under 6 months of age are most vulnerable to suffering from complications secondary to influenza infection.
- Trial name
- Piiitch (NCT00570037)
- Testing
- Trivalent inactivated influenza vaccine
- Where
- 2 sites in United States
- Volunteers
- 544 people, healthy volunteers welcome
- Sponsor
- Duke University
Acellular Pertussis, Tetanus
US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention…
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00282295
- Testing
- Boostrix®, Menactra™
- Where
- 24 sites in United States
- Volunteers
- 1,344 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Study of AERAS-402 in Healthy Infants
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
- Trial name
- NCT01198366
- Testing
- AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp
- Where
- 7 sites in Kenya, Mozambique and 1 more
- Volunteers
- 487 people, healthy volunteers welcome
- Sponsor
- Aeras
HIV Infections, Opioid-Related Disorders
Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
Drug abuse and HIV/AIDS are serious global health problems. Injection drug use is currently the major mode of transmission of HIV in many countries.
- Trial name
- NCT00270257
- Testing
- Buprenorphine/Naloxone
- Where
- 4 sites in China, Thailand
- Volunteers
- 1,251 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs).
- Trial name
- NCT01769456
- Testing
- PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Where
- 6 sites in United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Infection
Timing of Antibiotic Prophylaxis for Cesarean Deliveries
The current standard of care to prevent post partum infectious morbidities is to administer antibiotic prophylaxis to all women undergoing a cesarean delivery.
- Trial name
- NCT00805545
- Testing
- Antibiotic
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Florida
Infections, Meningococcal
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the…
- Trial name
- NCT00317109
- Testing
- Tritanrix™- HepB, Hiberix™, Mencevax™ ACW
- Where
- 3 sites in South Africa
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs).
- Trial name
- NCT00119106
- Testing
- Tenofovir disoproxil
- Where
- Thailand
- Volunteers
- 2,413 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention