Malaria in PregnancyPRIMVACLongTNCT05426187
Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Received Placental Malaria Vaccine
An observational study of Malaria in Pregnancy, run by Groupe de Recherche Action en Sante at 1 site in Burkina Faso.
Trial summary
Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years Sample Size: 90 Study duration: 21 months Subject duration: 12 months if pregnancy doesn't occurred. In case of pregnancy, the participant will be followed up until the delivery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Malaria in Pregnancy
- Type of treatment
- Vaccines
- How many people
- 90 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 18 Feb 2022to 31 Dec 2024
- 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 to 35 years
- Women only
- Adult
Study population: Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso. Women of the same age and nulligravid who did not participate in the phase 1b trial. Women of the same age and primigravid who did not participate in the phase 1b trial.
Who may be able to join
- Any participant of the previous PRIMVAC vaccine phase Ib trial
- Nulligravid and primigravid women aged 18-35 years
- Residing in study region and environs
- Available and willing to participate in follow-up for the duration of study
- Participant who accept blood sample collection
- Appear to be in generally good health based on clinical and laboratory investigation
- Signed informed consent
Who cannot join
- Participants who refused to sign informed consent
- Use of an investigational or non-registered drug or vaccine other than the previous study vaccine
- Chronic administration of immunosuppressants or other immune-modifying drugs
- Confirmed or suspected immunosuppressive or immunodeficient condition
- Confirmed or suspected autoimmune disease
- Simultaneous participation in any interventional clinical trial
- Women of control groups with positif pregnancy test at the enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Enrolled in a Phase 1b Clinical Trial With the PRIMVAC Placental Malaria Candidate Vaccine
Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years
Sample Size: 90
Read more
Study duration: 21 months
Subject duration: 12 months if pregnancy doesn't occurred. In case of pregnancy, the participant will be followed up until the delivery.
Study Design: Long term observational study comparing the immunology trend of 3 groups of i) women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso; ii) women of the same age and nulligravid who did not participate in the phase 1b trial iii) women of the same age and primigravid who did not participate in the phase 1b trial
Co Primary objectives
- To assess the dynamics of humoral immune response to the vaccine antigen during long term follow up of the study participants
- To evaluate the functional durability of the humoral immune responses of women who participated in the phase 1b vaccine trial compared to women of the same age
Secondary objectives
- To assess the cellular immune response during the follow-up period
- To assess the incidence of clinical malaria on study participants
- To assess the prevalence of Placental Malaria in study participants and adverse outcomes such as maternal anemia, low birth weight, stillbirth and prematurity.
Read the detailed description
It is a long-term observational study comparing the immunology trend of 3 groups of women:
- Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso
- Women of the same age and nulligravid who did not participate in the phase 1b trial
- Women of the same age and primigravid who did not participate in the phase 1b trial
The proposed cohort study will build on the previous phase 1b study which was conducted within the health district of Saponé (ClinicalTrials.gov Identifier: NCT02658253). The enrolment and follow up of the subjects will last 12 months. Pregnancy which occurred during the follow up period will monitored until the delivery. An additional six months is necessary for sample analysis in the laboratory, the data analysis and the preparation of reports and publications.
- Conditions
- Malaria in Pregnancy
- Keywords
- vaccine, nulligravid, immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso | |
| Group 2 | Women of the same age and nulligravid who did not participate in the phase 1b trial | |
| Group 3 | Women of the same age and primigravid who did not participate in the phase 1b trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer of antibodies
Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)
Measured: month 0
Geometric mean titer of antibodies
Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)
Measured: month 6
Geometric mean titer of antibodies
Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)
Measured: month 12
Cross-reactivity against different VAR2CSA variants expressed on the surface of erythrocytes parasitized by various strains of Plasmodium falciparum by flow cytometry
VAR2CSA variants
Measured: month 0
Percentage of binding inhibitory activity using various VAR2CSA expressing strains by CSA-binding inhibition assay (BIA) at different timepoints during the twelve months of follow up.
binding inhibitory activity
Measured: month 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start18 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria in PregnancyStudies 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
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe de Recherche Action en Sante
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, European Vaccine Initiative
- Responsible party
- Sponsor
- Investigators
- Alphonse Ouedraogo, MD, PhD, Principal investigator, Groupe de Recherche Action en Sante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426187
- Sponsor's protocol ID
- PRIMVAC Long Term study
- Acronym
- PRIMVACLongT
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Enrolled in a Phase 1b Clinical Trial With the PRIMVAC Placental Malaria Candidate Vaccine
- ClinicalTrials.gov ID
- NCT05426187
- Acronym / sponsor ID
- PRIMVACLongT / PRIMVAC Long Term study
- Conditions
- Malaria in Pregnancy
- Keywords
- vaccine, nulligravid, immunology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Groupe de Recherche Action en SanteUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, European Vaccine Initiative
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Jun 2022 (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.
Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years
Sample Size: 90
Study duration: 21 months
Subject duration: 12 months if pregnancy doesn't occurred. In case of pregnancy, the participant will be followed up until the delivery.
Study Design: Long term observational study comparing the immunology trend of 3 groups of i) women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso; ii) women of the same age and nulligravid who did not participate in the phase 1b trial iii) women of the same age and primigravid who did not participate in the phase 1b trial
Co Primary objectives
- To assess the dynamics of humoral immune response to the vaccine antigen during long term follow up of the study participants
- To evaluate the functional durability of the humoral immune responses of women who participated in the phase 1b vaccine trial compared to women of the same age
Secondary objectives
- To assess the cellular immune response during the follow-up period
- To assess the incidence of clinical malaria on study participants
- To assess the prevalence of Placental Malaria in study participants and adverse outcomes such as maternal anemia, low birth weight, stillbirth and prematurity.
Detailed description
It is a long-term observational study comparing the immunology trend of 3 groups of women:
- Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso
- Women of the same age and nulligravid who did not participate in the phase 1b trial
- Women of the same age and primigravid who did not participate in the phase 1b trial
The proposed cohort study will build on the previous phase 1b study which was conducted within the health district of Saponé (ClinicalTrials.gov Identifier: NCT02658253). The enrolment and follow up of the subjects will last 12 months. Pregnancy which occurred during the follow up period will monitored until the delivery. An additional six months is necessary for sample analysis in the laboratory, the data analysis and the preparation of reports and publications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso |
| Group 2 | – | –Women of the same age and nulligravid who did not participate in the phase 1b trial |
| Group 3 | – | –Women of the same age and primigravid who did not participate in the phase 1b trial |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso. Women of the same age and nulligravid who did not participate in the phase 1b trial. Women of the same age and primigravid who did not participate in the phase 1b trial.
Key inclusion criteria (7 listed)
- Any participant of the previous PRIMVAC vaccine phase Ib trial
- Nulligravid and primigravid women aged 18-35 years
- Residing in study region and environs
- Available and willing to participate in follow-up for the duration of study
- Participant who accept blood sample collection
Key exclusion criteria (7 listed)
- Participants who refused to sign informed consent
- Use of an investigational or non-registered drug or vaccine other than the previous study vaccine
- Chronic administration of immunosuppressants or other immune-modifying drugs
- Confirmed or suspected immunosuppressive or immunodeficient condition
- Confirmed or suspected autoimmune disease
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
Geometric mean titer of antibodies
Time frame: month 0
Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)
Geometric mean titer of antibodies
Time frame: month 6
Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)
Geometric mean titer of antibodies
Time frame: month 12
Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)
Cross-reactivity against different VAR2CSA variants expressed on the surface of erythrocytes parasitized by various strains of Plasmodium falciparum by flow cytometry
Time frame: month 0
VAR2CSA variants
Percentage of binding inhibitory activity using various VAR2CSA expressing strains by CSA-binding inhibition assay (BIA) at different timepoints during the twelve months of follow up.
Time frame: month 0
binding inhibitory activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- 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.
Alphonse Ouedraogo, MD, PhD principal investigator
Groupe de Recherche Action en Sante
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 Malaria in Pregnancy, run by Groupe de Recherche Action en Sante at 1 site in Burkina Faso.
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 7 inclusion and 7 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 18 Apr 2024. 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 Burkina Faso. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer of antibodies (time frame: month 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2024.