Yellow Fever VaccineNCT04416477
Duration of Immunity 10 Years After a Dose-response Study With Yellow Fever Vaccine - Complementary Study
An observational study of Yellow Fever Vaccine, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial summary
Yellow fever is an acute febrile infectious disease transmitted to man urban cycle by mosquitoes infected by an arbovirus of the genus Flavivirus family Flaviviridae. Its occurrence is recorded in South America Central America and Africa. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Yellow Fever Vaccine
- How many people
- 255 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Apr 2019to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: Participants will be healthy male adults who received the first dose of the yellow fever vaccine in 2009 when they participated in the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz". Participation in the study will be documented at the time of signing the Informed Consent Form.
Who may be able to join
- Have participated as a volunteer of the study carried out in 2009.
- Seronegative volunteers before vaccination in the study "Dose-response study of yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz" carried out in 2009. Non-revaccinated volunteers, seropositive in the study "Duration of immunity to yellow fever in volunteers eight years after a dose-response study", conducted in 2017.
- Not having received another yellow fever vaccine after participating in the study "Dose-response study of the yellow fever vaccine produced by Bio-Manguinhos / Fiocruz" carried out in 2009 and the study "Duration of immunity to yellow fever in volunteers eight years after a dose-response study", conducted in 2017.
- Available to follow up during the field study period.
- Agree to give name, address, phone, and other contact information, if necessary.
- Agree to strictly follow the study protocol.
Show all 9Show fewer
- Able to understand and sign the Informed Consent Form (ICF).
- Understand the impossibility of participating in another clinical trial during the time of participation in this study.
- Note: Individuals with a history of travel to areas endemic for yellow fever may be included but will be analyzed separately.
Who cannot join
- Refusal to collect biological material (blood).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Unidade de Ensaios Clínicos em Imunobiológicos / Instituto de Tecnologia em Imunobiológicos de Bio-Manguinhos / Fiocruz
Rio de Janeiro, Rio de Janeiro, 21040-900
Akira Homma, +55 (21) 3882-9479, Akira@bio.fiocruz.br
Maria de Lourdes de Sousa Maia, +55 (21) 3882-9474, lourdes.maia@bio.fiocruz.br
About this study
Yellow fever is an acute febrile infectious disease transmitted to man urban cycle by mosquitoes infected by an arbovirus of the genus Flavivirus family Flaviviridae. Its occurrence is recorded in South America Central America and Africa. In cities the yellow fever vector is the Aedes aegypti mosquito which also transmits dengue viruses zika and chikungunya. This disease is more frequent in males and the most affected age group is above fifteen years due to the greater exposure related to the penetration in wild areas of the endemic zone of yellow fever. Another risk group is unvaccinated people who live near wild environments where the virus circulates. According to the World Health Organization a single dose of the yellow fever vaccine is sufficient to maintain protective immunity against yellow fever for a lifetime therefore a booster dose is not required. This question is difficult to evaluate because there is no serological correlate of protection against yellow fever and seropositivity is defined with several cut off points. Although studies indicate that the duration of protection after vaccination is long there is considerable evidence in the literature that antibody titer falls over the years reaching levels considered as seronegative in at least a portion of the vaccinees. This is of more concern to people living in endemic areas who are exposed to the virus throughout their lives. For this reason Brazil recommended revaccinating once at least until additional studies were done. The need to increase Bio Manguinhos production capacity to meet the increased demand from Brazil and other countries is urgent. The occurrence of epidemics when millions of individuals need to be vaccinated in a short period of time exceeds production capacity and this is a recurrent problem. The current vaccine has a very high potency well above the thousand international units recommended by World Health Organization. But we need to generate additional evidence that very low doses of viral particles in the yellow fever vaccine are still immunogenic and that their immunogenicity can be maintained for at least ten years after vaccination. This evidence will support the rapid increase of their availability by the fractionation of doses or other alternatives.
Read the detailed description
This is an observational study in young adult males who received the first dose of the yellow fever vaccine when they participated in the Dose response study of the yellow fever vaccine produced by Bio Manguinhos Fiocruz. The purpose of this study is to know whether reduced dose immunity is maintained for at least ten years. This information is crucial to support the recommendation to use fractional dose in adults a topic of great interest to World Health Organization.
- Conditions
- Yellow Fever Vaccine
- Keywords
- Immunity duration
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals who were protected 10 years after the first dose of the yellow fever vaccine, assessed by the neutralization test
Serological status of yellow fever in adult individuals 10 years after seroconversion in a low dose or full dose study of the 17DD yellow fever vaccine produced by Bio-Manguinhos / Fiocruz.
Measured: 10 years after the first dose of yellow fever vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start8 Apr 2019
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Yellow Fever VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Akira Homma, Principal investigator, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos / FIOCRUZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416477
- Sponsor's protocol ID
- ASCLIN 001/2019
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vianna CM, Noronha TG, Camacho LAB, Andrade RC, de Souza Brum RC, Dos Santos EM, Aguiar DF, Dos Santos MLB, de Souza Cruz RL, de Lima SMB, de Souza Azevedo Soares A, Schwarcz WD, da Matta de Castro T, Xavier JR, da Conceicao DA, Homma A, de Lourdes de Sousa Maia M. Duration of post-vaccination immunity to yellow fever in volunteers ten years after a dose-response study - A complementary study. Vaccine. 2024 Oct 24;42(24):126083. doi: 10.1016/j.vaccine.2024.06.050. Epub 2024 Jun 25.
PubMed 38926068
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Immunity 10 Years After a Dose-response Study With Yellow Fever Vaccine - Complementary Study
- ClinicalTrials.gov ID
- NCT04416477
- Acronym / sponsor ID
- ASCLIN 001/2019
- Conditions
- Yellow Fever Vaccine
- Keywords
- Immunity duration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Yellow fever is an acute febrile infectious disease transmitted to man urban cycle by mosquitoes infected by an arbovirus of the genus Flavivirus family Flaviviridae. Its occurrence is recorded in South America Central America and Africa. In cities the yellow fever vector is the Aedes aegypti mosquito which also transmits dengue viruses zika and chikungunya. This disease is more frequent in males and the most affected age group is above fifteen years due to the greater exposure related to the penetration in wild areas of the endemic zone of yellow fever. Another risk group is unvaccinated people who live near wild environments where the virus circulates. According to the World Health Organization a single dose of the yellow fever vaccine is sufficient to maintain protective immunity against yellow fever for a lifetime therefore a booster dose is not required. This question is difficult to evaluate because there is no serological correlate of protection against yellow fever and seropositivity is defined with several cut off points. Although studies indicate that the duration of protection after vaccination is long there is considerable evidence in the literature that antibody titer falls over the years reaching levels considered as seronegative in at least a portion of the vaccinees. This is of more concern to people living in endemic areas who are exposed to the virus throughout their lives. For this reason Brazil recommended revaccinating once at least until additional studies were done. The need to increase Bio Manguinhos production capacity to meet the increased demand from Brazil and other countries is urgent. The occurrence of epidemics when millions of individuals need to be vaccinated in a short period of time exceeds production capacity and this is a recurrent problem. The current vaccine has a very high potency well above the thousand international units recommended by World Health Organization. But we need to generate additional evidence that very low doses of viral particles in the yellow fever vaccine are still immunogenic and that their immunogenicity can be maintained for at least ten years after vaccination. This evidence will support the rapid increase of their availability by the fractionation of doses or other alternatives.
Detailed description
This is an observational study in young adult males who received the first dose of the yellow fever vaccine when they participated in the Dose response study of the yellow fever vaccine produced by Bio Manguinhos Fiocruz. The purpose of this study is to know whether reduced dose immunity is maintained for at least ten years. This information is crucial to support the recommendation to use fractional dose in adults a topic of great interest to World Health Organization.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Participants will be healthy male adults who received the first dose of the yellow fever vaccine in 2009 when they participated in the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz". Participation in the study will be documented at the time of signing the Informed Consent Form.
Key inclusion criteria (9 listed)
- Have participated as a volunteer of the study carried out in 2009.
- Seronegative volunteers before vaccination in the study "Dose-response study of yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz" carried out in 2009. Non-revaccinated volunteers, seropositive in the study "Duration of immunity to yellow fever in volunteers eight years after a dose-response study", conducted in 2017.
- Not having received another yellow fever vaccine after participating in the study "Dose-response study of the yellow fever vaccine produced by Bio-Manguinhos / Fiocruz" carried out in 2009 and the study "Duration of immunity to yellow fever in volunteers eight years after a dose-response study", conducted in 2017.
- Available to follow up during the field study period.
- Agree to give name, address, phone, and other contact information, if necessary.
Key exclusion criteria (1 listed)
- Refusal to collect biological material (blood).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of individuals who were protected 10 years after the first dose of the yellow fever vaccine, assessed by the neutralization test
Time frame: 10 years after the first dose of yellow fever vaccine
Serological status of yellow fever in adult individuals 10 years after seroconversion in a low dose or full dose study of the 17DD yellow fever vaccine produced by Bio-Manguinhos / Fiocruz.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 38926068Vianna CM, Noronha TG, Camacho LAB, Andrade RC, de Souza Brum RC, Dos Santos EM, Aguiar DF, Dos Santos MLB, de Souza Cruz RL, de Lima SMB, de Souza Azevedo Soares A, Schwarcz WD, da Matta de Castro T, Xavier JR, da Conceicao DA, Homma A, de Lourdes de Sousa Maia M. Duration of post-vaccination immunity to yellow fever in volunteers ten years after a dose-response study - A complementary study. Vaccine. 2024 Oct 24;42(24):126083. doi: 10.1016/j.vaccine.2024.06.050. Epub 2024 Jun 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akira Homma principal investigator
Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos / FIOCRUZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Yellow Fever Vaccine, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akira Homma (+55 (21) 3882-9479, Akira@bio.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals who were protected 10 years after the first dose of the yellow fever vaccine, assessed by the neutralization test (time frame: 10 years after the first dose of yellow fever vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.