Clinical trials: Non-Specific Effects of Vaccines
Measles Vaccine, Hospital Admission
Measles Vaccination at Health System Contacts
In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and…
- Conditions
- Measles Vaccine, Hospital Admission, Mortality, Non-specific (Heterologous) Effects of Vaccines
- Trial name
- NCT04220671
- Testing
- measles vaccine, Saline
- Where
- Guinea-Bissau
- Volunteers
- 5,400 people
- Sponsor
- Bandim Health Project
Malaria
Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine
BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality.
- Trial name
- NCT00126217
- Testing
- Bacille Calmette Guerin (BCG)
- Where
- Guinea-Bissau
- Volunteers
- 2,871 people
- Sponsor
- Bandim Health Project
Healthy
Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine
The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune…
- Trial name
- VSG-2011-101 (NCT01578070)
- Testing
- 0.2μg Act-HIB®, ViscoGel® and 0.2μg Act-HIB®, ViscoGel® and 2μg Act-HIB®
- Where
- Sweden
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Viscogel AB
Tuberculosis
Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?
The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks.
- Trial name
- NCT00146302
- Testing
- Bacille Calmette Guerin (BCG)
- Where
- Guinea-Bissau
- Volunteers
- 2,320 people
- Sponsor
- Bandim Health Project
Heterologous Immunity, Infant Morbidity
Comparing Morbidity and Mortality Effects of Two Different Strains of BCG
Background: Investigators at Bandim Health Project (BHP, www.bandim.org) in Guinea-Bissau have shown in several randomized trials that the Bacille-Calmette-Guérin (BCG) vaccine against tuberculosis (TB) is associated with reduced…
- Conditions
- Heterologous Immunity, Infant Morbidity, Infant Mortality, Trained Immunity
- Trial name
- NCT03400878
- Testing
- BCG-Japan, BCG-Russia
- Where
- 2 sites in Guinea-Bissau
- Volunteers
- 17,505 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Respiratory Tract Infections, Infections
Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children
The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.
- Conditions
- Respiratory Tract Infections, Infections, Allergy, Eczema
- Trial name
- NEMAU (NCT05758532)
- Testing
- Measles-Mumps-Rubella vaccine (MMR)
- Where
- Switzerland
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Laure Pittet, MD-PhD
Non Specific Effects of Vaccine, Bacillus-Calmette-Guerin
Low Birth Weight Follow-up
The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will…
- Conditions
- Non Specific Effects of Vaccine, Bacillus-Calmette-Guerin, Low Birth Weight, Maternal Immunisation
- Trial name
- NCT03020147
- Where
- Guinea-Bissau
- Volunteers
- 1,258 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Vaccine Reaction
The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau
OPV is the live attenuated vaccine against polio virus. OPV has been key in almost eradicating polio infection. Intriguingly, OPV has been associated with lower all-cause mortality and morbidity.
- Trial name
- NCT06266754
- Testing
- Oral polio vaccine
- Where
- Guinea-Bissau
- Volunteers
- 80 people
- Sponsor
- Bandim Health Project
Measles Vaccination, Oral Polio Vaccine
Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children
The world is set on eradicating measles and polio infections in the coming decade. Once both infections are under control, campaigns with measles and oral polio vaccines will be phased out.
- Conditions
- Measles Vaccination, Oral Polio Vaccine, Non-specific/Heterologous Effects of Vaccines, Mortality
- Trial name
- RE-CAMP (NCT03460002)
- Testing
- Measles vaccine, Oral polio vaccine
- Where
- Guinea-Bissau
- Volunteers
- 28,612 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Measles Vaccine
Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso.
Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV.
- Trial name
- NCT01668745
- Testing
- Early measles vaccine
- Where
- Burkina Faso
- Volunteers
- 4,559 people
- Sponsor
- Bandim Health Project
Covid19, Non-specific Effects of Vaccines
Using BCG to Protect Senior Citizens During the COVID-19 Pandemic
Background: The virus SARS-CoV-2 has spread rapidly throughout the world. Seniors are at high risk of severe COVID-19 when infected.
- Conditions
- Covid19, Non-specific Effects of Vaccines, Heterologous Immunity, Morbidity
- Trial name
- NCT04542330
- Testing
- BCG-Denmark, Saline
- Where
- Denmark
- Volunteers
- 1,700 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Measles, Diphtheria
Immunology of Non-specific Effects of Vaccine
OBJECTIVES General: To investigate the immunological background for the non-specific effects of diphtheria-tetanus-pertussis (DTP) and measles vaccines on child mortality Specific: Examine the cytokine responses and possible…
- Conditions
- Measles, Diphtheria, Tetanus, Pertussis
- Trial name
- NCT00168545
- Testing
- Measles vaccine
- Where
- Guinea-Bissau
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Poliovirus Vaccine, Oral, COVID
OPV as Potential Protection Against COVID-19
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio.
- Conditions
- Poliovirus Vaccine, Oral, COVID, Mortality, Morbidity
- Trial name
- NCT04445428
- Testing
- oral polio vaccine + information, Information
- Where
- Guinea-Bissau
- Volunteers
- 3,729 people
- Sponsor
- Bandim Health Project
HIV Infections
Controlling Acute or Early HIV Infection With Antiretroviral Drugs, Without a Candidate Vaccine.As Reported Previously, the Candidate Vaccie Was Not Provided by the Maufacturer as Promised
The purpose of this study is to determine the role of HIV-specific CD4 T cell responses and immune responses dependent upon these CD4 responses that develop when antiretroviral drugs are started during acute or recent HIV…
- Trial name
- NCT00238459
- Testing
- Patients elected to take licensed drugs. The vaccine was not provided for evaluation, multiple licensed drugs not randomized, multiple licensed antiretroviral drugs; not randomized
- Where
- 2 sites in United States, Canada
- Volunteers
- 58 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infant Mortality, BCG
Can BCG Vaccination at First Health-facility Contact Reduce Early Infant Mortality?
Bacillus Calmette-Guérin (BCG) vaccination is recommended at birth to protect against tuberculosis (TB) in countries with high TB burden. BCG is supplied in multidose vials with limited durability after reconstitution.
- Trial name
- CS-BCG (NCT04658680)
- Testing
- BCG vaccination at first health facility contact
- Where
- Guinea-Bissau
- Volunteers
- 22,800 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
COVID-19
Non-specific Effects of FLU-MMR Vaccines in Adults
Various observational studies have reported an association between influenza vaccination and lower rates of infection with SARS-Cov-2 and less COVID-19 disease severity have been reported in large epidemiological studies in US…
- Trial name
- FLUMMR-BRA (NCT05401448)
- Testing
- Influenza, MMR vaccines
- Where
- Brazil
- Volunteers
- 638 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Death; Neonatal, Death, Infant
Trial to Compare BCG-Bulgaria and BCG-Denmark
The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of Hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines…
- Conditions
- Death; Neonatal, Death, Infant, Morbidity;Newborn, Morbidity;Infant
- Trial name
- BCGSTRAIN IV (NCT05397678)
- Testing
- BCG-Denmark, BCG-Bulgaria
- Where
- Guinea-Bissau
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Vaccine Reaction, Anemia
Non-specific Effects of Vaccination on Mortality and Morbidity
It has long been recognized that the positive effects of vaccination on childhood mortality cannot be solely attributed to a decline in the disease targeted by the vaccine.
- Conditions
- Vaccine Reaction, Anemia, Malaria,Falciparum, Salmonella Bacteraemia
- Trial name
- NOVAC (NCT03176719)
- Testing
- Venipuncture
- Where
- Burkina Faso
- Volunteers
- 1,005 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Atopic Dermatitis
Does Timeliness of DTaP-IPV-Hib Vaccination Affect Development of Atopic Dermatitis Before 1 Year of Age?
It has been found that the non-live vaccine against Diphtheria, Tetanus, and Pertussis (DTP) in addition to its disease specific effects may have so called "non-specific effects" with the potential to affect sensitivity towards…
- Trial name
- NCT03142139
- Testing
- RQ1a: Delayed vs. timely vaccination with the 1st dose of DTaP-IPV-Hib, RQ1b: Delayed vs. timely vaccination with the 2nd dose of DTaP-IPV-Hib, RQ2: Vaccination with DTaP-IPV-Hib compared to being unvaccinated
- Volunteers
- 1,027,559 people
- Sponsor
- Bandim Health Project
Heterologous Effects of Vaccines
Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Challenge in the Elderly
Vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine.
- Trial name
- NCT02765126
- Testing
- Seasonal influenza vaccine, Diphtheria-tetanus-acellular pertussis vaccine
- Where
- Australia
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Clifford Craig Medical Research Trust