A Phase 3 interventional study of MVA-BN standard regimen and MVA-BN standard regimen (Administered as PEP) in Neonate, Maternal Transmission and Mpox, sponsored by Jean-Pierre Van geertruyden. Active, not recruiting at 1 site in Democratic Republic of the Congo. Open to female participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Jean-Pierre Van geertruyden · Phase 3, Interventional, and Prevention
This Phase 3 open-label study aims to assess the safety and immune response of the MVA-BN mpox vaccine when administered subcutaneously to pregnant and postpartum women in the Democratic Republic of the Congo (DRC), a population at high risk of mpox infection. The study will be conducted in Boende, Tshuapa Province, DRC.
A total of 359 maternal participants, aged 16 to 35 and in their second or third trimester of pregnancy, will be enrolled. Participants will be randomly assigned to receive two subcutaneous doses of the MVA-BN vaccine, given 28 days apart, either during pregnancy (Maternal Group 1) or within 72 hours after delivery (Maternal Group 2). Additionally, pregnant women in any trimester who have been recently exposed to a confirmed mpox case will be enrolled in the post-exposure prophylaxis (PEP) arm (Maternal Group 3), receiving the vaccine as soon as possible after exposure-ideally within four days but up to 14 days if they remain asymptomatic.
The study will evaluate the safety, reactogenicity, and immune responses of vaccinated pregnant women compared to healthy adults in the POX-MVA-045 study (NCT06549530) through non-inferiority analyses. Participants will be monitored for immunogenicity and safety for 13 months post-delivery, while neonates will be observed for safety over the same period. The trial will also compare outcomes between women vaccinated during pregnancy and those vaccinated postpartum, assess the transfer of maternal immunity to neonates, and explore correlations between maternal antibody levels in serum and breast milk.
This study seeks to provide strong evidence supporting the safety and immunogenicity of the MVA-BN mpox vaccine in pregnancy, contributing to global public health efforts to protect at-risk women and their infants in mpox-endemic regions.
This open-label, Phase 3 study aims to evaluate the immunogenicity and safety of the MVA-BN standard regimen (1x10⁸ TCID50 Inf.U./0.5mL) administered subcutaneously in two doses, 28 days apart, to pregnant women and women in the immediate postpartum period (\<72 hours after delivery). As described in the study protocol, the main study consists of the vaccination and safety and immunogenicity follow-up of pregnant and postpartum women. A sub-study will evaluate the transmission of antibodies from mother to child either during pregnancy of via breast milk.
The trial plans to enrol 359 participants, aged 16 to 35 years, with a gestational age between 13 and 32 weeks. Participants will be randomised into three groups: Maternal Group 1 (N=215), vaccinated during pregnancy; Maternal Group 2 (N=144), vaccinated within 72 hours postpartum; and Maternal Group 3 (N=convenience sampling), which includes pregnant women exposed to a confirmed mpox case within the past 14 days but who remain asymptomatic and will be offered post-exposure prophylaxis (PEP).
The study will be conducted at the General Reference Hospital of Boende, located in Boende, Tshuapa Province, Democratic Republic of Congo (DRC), with two satellite sites (Motema Mosantu and Marie-Louise Health Centres) supporting maternal delivery, vaccination for Maternal Group 2, and immediate postpartum sample collection, where applicable.
During the screening visit (SCR), interested participants will undergo an evaluation (test of understanding) to ensure understanding of the study and provide informed consent (or assent for minors). Demographics, vaccination history, and medical history will be recorded. Participants' general health will be evaluated through a physical examination, urine testing, and a gynaecological ultrasound to confirm gestational age. Blood samples will be collected for haematology, biochemistry, and infection screening for HIV, hepatitis B, syphilis, and malaria. After enrolling participants will be randomised to Maternal Group 1 or Maternal Group 2, unless they have been exposed to mpox in the past 14 days, then they will enrolled in Maternal group 3. All AEs, including serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs), will be monitored from enrolment until 13 months after delivery.
The prenatal visits (PN) are scheduled according to gestational age: PN Visit 1 (15-18 weeks), PN Visit 2 (24-28 weeks), PN Visit 3 (28-32 weeks), and PN Visit 4 (36-38 weeks). The number of visits will depend on the participant's enrolment date. Where feasible and applicable, prenatal visits will be combined with screening and/or vaccination visits. At each visit, vital signs and anthropometric measurements (weight, height, and fundal height) will be recorded to monitor maternal health and foetal growth. Urinary tests for infections will be performed at each visit, and a glucose challenge test (GCT) at 24-28 weeks will screen for gestational diabetes. Ultrasounds will also be performed as needed to evaluate gestational health. All participants will receive Intermittent Preventive Treatment for malaria (IPTp) according to WHO guidelines, with doses spaced at least one month apart.
On Day 0, participants' vital signs (blood pressure, heart rate, respiratory rate, and temperature) will be assessed. Blood samples will be collected from mothers to establish baseline immunogenicity, including neutralising antibodies (PRNTs), total binding antibodies (ELISA), and IgG binding antibodies (LUMINEX assay) against vaccinia and mpox viruses. To minimise inconvenience and where possible and applicable, samples for haematology and biochemistry will be collected simultaneously. Afterwards, participants will receive their first dose of the MVA-BN vaccine and a participant journal to record any solicited or unsolicited adverse events (AEs).
Seven days after the first vaccine dose (Day 0), the participant will be asked to return with the journal to record data on solicited AEs and unsolicited AEs (UAEs). Ongoing solicited AEs at this visit will be followed up until resolution and UAEs will be followed up until 28 days post-vaccination and inquired about before the second vaccine dose.
On Day 28, physical examinations of the mother will be conducted. Participants will receive the second MVA-BN vaccine dose, and blood samples will be collected from mothers to measure neutralising antibodies (PRNTs), total binding antibodies (ELISA), and IgG binding antibodies (LUMINEX assay). Participants will also receive a second participant journal to record any AEs.
Seven days after the first vaccine dose (Day 35), the participant will be asked to return with the journal to record data on solicited AEs and unsolicited AEs (UAEs). Ongoing solicited AEs at this visit will be followed up until resolution and UAEs will be followed up until 28 days post-vaccination during a telephone or home visit on Day 56.
On Day 42, blood samples will be collected from mothers to evaluate the persistence of vaccine-induced antibodies.
On Day 56, ongoing solicited AEs will be followed up and any ongoing or new UAEs be assessed/followed up via telephone or home visit.
On delivery day (Dd), a cord blood sample will be collected to measure neutralising antibodies (PRNTs), total binding antibodies (ELISA), and IgG binding antibodies (LUMINEX assay). Within 72 hours postpartum, colostrum (breast milk) samples will be collected to measure IgA antibody levels using the LUMINEX assay, reflecting maternal immunity transfer through breastfeeding. Physical examinations of both the mother and neonate will be conducted. Neonatal assessments will include APGAR scores at 1 and 5 minutes, general appearance, measurements (weight, length, and head circumference), and reflexes. Maternal assessments will focus on recovery and any postpartum complications. Maternal Group 2 will be vaccinated within 72 hours postpartum with the first MVA-BN dose, this will be Day 0 for this Group. All other visits from Day 0-Day 56 will take place for this group as described above. The Day 42 visit corresponds with the 6 week post-partum visit. Activities for both visits will be combined in to one visit.
Post-delivery visits will occur at 6 weeks, 12 weeks, 6 months and 13 months post delivery for all participants. Mothers and neonates will undergo follow-up assessments, including physical examinations of neonates to evaluate growth and developmental milestones. Blood samples will be collected from mothers at each visit to monitor the durability of vaccine-induced antibodies. Additionally, breast milk samples will be collected on at 6 weeks, 12 weeks, 6 months and 13 months post delivery to evaluate IgA binding antibody levels. At 6 weeks and 12 weeks postpartum visits, IgG binding antibodies in breast milk will also be determined. Blood samples from neonates will be collected on at 6 weeks, 12 weeks and 6 months after birth to assess neutralising antibodies (PRNTs), total binding antibodies (ELISA), and IgG binding antibodies (LUMINEX assay).
72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.
This study's planned enrollment of 359 is above the median of 305 across 36 interventional studies indexed under Mpox, Monkeypox.
Browse Mpox, Monkeypox studies →Jean-Pierre Van geertruyden is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
The participant must pass (≥9/10) the Test of Understanding after being advised of the risks and benefits of the trial in a language understood by the participant and before performing any trial-specific procedures.
The participant must sign and date an form (≥18 years old) or assent form (16-17 years old) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study.
The participant must be in her second (13-27 weeks) or early third trimester (28-32 weeks) of pregnancy at the time of vaccination.
- Note: Mpox-infected and exposed pregnant women (Maternal group 3) can enrol at any stage of the pregnancy.
- Note: Depending on enrolment progress of pregnant women between 13 and 32 weeks gestation, pregnant women in their first trimester may be enrolled but will not be vaccinated until they reach 13 weeks gestation. Sponsor approval needs to be sought to start enrolling pregnant women earlier than 13 weeks gestation.
The participant and her unborn child must be generally healthy in the investigator's clinical judgment and on the basis of vital signs assessed at day 1 screening with no severe (chronic) conditions (as far as medically known) that might interfere with vaccine assessment.
- Note: -positive subjects can be enrolled as long as their general condition is good, i.e., HIV infection under stable Highly Active Antiretroviral Therapy (HAART; no change within the last three month) and/or >500/ μL, no signs or symptoms of . Pregnant HIV-positive participants must agree to attend all prenatal visits foreseen in the time and events schedule for regular follow-up.
Inclusion criteria for the Maternal Group 3:
1. Close contact in the 2 weeks prior to signing the ICF with anyone known to have mpox.
Exclusion Criteria:
Close contact in the 2 weeks before signing the ICF with anyone known to have mpox.
- Note: not applicable to Maternal Group 3
Acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of responses, including but not limited to neurologic, cardiovascular, respiratory, hepatic, hematologic, rheumatologic, endocrine, gastrointestinal, renal, autoimmune, or immunosuppressive conditions.
- Note: Participants with minor acute illnesses such as mild diarrhoea or mild upper respiratory tract infection or temperature ≥38.0ºC at screening will be excluded from enrolment at that time but may be rescheduled for re-screening later if feasible.
Presence of significant medical conditions or findings at screening or vital signs for which, in the opinion of the gynaecologist/medical doctor, participation would not be in the best interest of the participant (e.g., compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day or any other immune-modifying drugs from 3 months before the first trial vaccination to the visit at the end of the active trial period (use of topical, inhaled, ophthalmic, and nasal is allowed).
- Note: Participants receiving antiretroviral (ARV) medication for the management of HIV infection are eligible for inclusion, provided they meet inclusion criterion 5.
Received an investigational or nonregistered drug or vaccine or used an invasive investigational or nonregistered medical device within 30 days prior to vaccination or current or planned participation in another clinical study during the study.
- Note: Participation in an observational clinical study is allowed.
Additional inclusion criteria for Maternal Group 3:
1. No symptoms at the time of reporting/vaccination.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women in Maternal Group 1 (vaccination during pregnancy), will receive the first of two MVA-BN vaccine doses, subcutaneously, in the second or third trimester of pregnancy, yet before 32 weeks of gestation. Ideally, both doses are administered during pregnancy.
Biological: MVA-BN standard regimen
Women in Maternal Group 2 (vaccinated postpartum), will receive the first of two MVA-BN vaccine doses, subcutaneously, ≤72 hours after delivery, preferably before discharge from the hospital/maternal health clinic (if applicable), unless contraindicated by the gynaecologist.
Biological: MVA-BN standard regimen
Women exposed to clinically or laboratory-confirmed mpox cases (Maternal Group 3) will preferably be vaccinated within 4 days after exposure. However the vaccine will be provided until 14 days after exposure if no symptoms are present.
Biological: MVA-BN standard regimen (Administered as PEP)
Historical data from healthy adults aged 18 to 50 years old from the POX-MVA-045 study (NCT06549530), will be used for safety and immunogenicity (non-inferiority) comparisons.
Biological: MVA-BN standard regimen
The MVA-BN vaccine, with the active ingredient: Modified Vaccinia Ankara-Bavarian Nordic, will be administered as a standard two-dose regimen at 1x10\^8 TCID50 Inf.U./0.5 mL. The doses will be given 28 days apart (±3 days) via subcutaneous injection into the deltoid muscle, preferably in the non-dominant arm.
MVA-BN. Post Exposure Prophylaxis (PEP) The MVA-BN vaccine, with the active ingredient: Modified Vaccinia Ankara-Bavarian Nordic, will be administered as a standard two-dose regimen at 1x10\^8 TCID50 Inf.U./0.5 mL. The doses will be given 28 days apart (±3 days) via subcutaneous injection into the deltoid muscle, preferably in the non-dominant arm. For Maternal Group 3, MVA-Bn will be administered as PEP as soon as possible after exposure, preferably within 4 days after exposure. However, as per WHO guidelines, PEP will be offered up to 14 days after exposure if the pregnant woman has not yet developed symptoms.
Main study: Neutralising antibody response post-dose 2 vaccination with MVA-BN
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting neutralising antibodies against the vaccinia virus in women vaccinated during pregnancy compared to adults of the POX-MVA-045 study at 2 weeks after the second dose.
Time frame: 14 days after the second dose
Safety and reactogenicity of the MVA-BN vaccine in pregnant women
To assess the safety and reactogenicity of the MVA-BN standard regimen, administered SC, in pregnant women compared to adults of the POX-MVA-045 study.
Time frame: Throughout the trial period; from first vaccination to 13 months postpartum.
Neonatal/infant safety outcomes in offspring of vaccinated mothers
To assess the safety in neonates/infants born to mothers vaccinated during pregnancy and mothers vaccinated postpartum.
Time frame: Throughout the trial period; from delivery to 13 months postpartum.
Maternal, fetal, and neonatal outcomes in vaccinated women
To describe maternal, foetal and neonatal outcomes in the cohort vaccinated during pregnancy, compared to the cohort vaccinated postpartum (control) and, if possible, the outcomes of pregnancy surveillance in Boende for the duration of the study.
Time frame: From vaccination to 13 months postpartum
Sub-study. Maternal immunity transferred via breastmilk
To assess immunogenicity in infants at birth by measuring the amount of total binding antibodies against the vaccinia virus, neutralising antibodies against the vaccinia virus, IgG binding antibodies against the vaccinia and mpox viruses in cord blood from women vaccinated during pregnancy compared to women vaccinated in the postpartum.
Time frame: At delivery
Immunogenicity in maternal serum post-vaccination
To assess the immunogenicity in mothers of the MVA-BN standard regimen, administered SC, in eliciting IgG binding antibodies against vaccinia and monkeypox virus in maternal blood from women vaccinated during pregnancy compared to women vaccinated in the postpartum at baseline (prior to vaccination), 2 weeks after the second dose, at delivery (when not the same as baseline), and at 6 weeks, 12 weeks, 6 months, and 13 months postpartum.
Time frame: Baseline to 13 months postpartum
Maternal immunity transferred via breastmilk (IgA antibodies)
To assess maternal immunity transferred via breastmilk by measuring IgA binding antibodies against vaccinia and monkeypox virus in breastmilk samples from women vaccinated during pregnancy compared to women vaccinated in the postpartum period in colostrum, at 6 weeks, 12 weeks, 6 months and 13 months postpartum.
Time frame: Delivery to 13 months postpartum
Maternal immunity transferred via breastmilk (IgG antibodies)
To assess maternal immunity transferred via breastmilk by measuring IgG binding antibodies against vaccinia and monkeypox virus in breastmilk samples from women vaccinated during pregnancy compared to women vaccinated in the postpartum period at 6 weeks and 12 weeks postpartum.
Time frame: 6 weeks and 12 weeks postpartum
Persistence of maternal immunity in infants
To assess persistence of maternal immunity in infants by measuring neutralising antibodies against the vaccinia virus, total binding antibodies against the vaccinia virus, IgG binding antibodies against vaccinia and monkeypox viruses in the infant's blood born from women vaccinated during pregnancy compared to women vaccinated in the postpartum at 6 weeks, 12 weeks, and 6 months postpartum.
Time frame: 6 weeks to 6 months postpartum
Neutralising antibody response in women vaccinated during pregnancy and adult of the POX-MVA-045 study
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting neutralising antibodies against the vaccinia virus in women vaccinated during pregnancy compared to adults of the POX-MVA-045 study at baseline and all blood collection time points after the second dose.
Time frame: Baseline to 13 months postpartum
Neutralising antibody response in women vaccinated in the immediate postpartum and adult of the POX-MVA-045 study
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting neutralising antibodies against the vaccinia virus in women vaccinated in the immediate postpartum period compared to adults of the POX-MVA-045 study at baseline and all blood collection time points after the second dose.
Time frame: Delivery to 13 months postpartum
Neutralising antibody response in women vaccinated during pregnancy and women vaccinated in the immediate postpartum
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting neutralising antibodies against the vaccinia virus in women vaccinated during pregnancy compared to women vaccinated in the postpartum, at baseline, 6 weeks, 12 weeks, 6 months and 13 months after delivery.
Time frame: Baseline to 13 months postpartum
Binding antibody reponse in women vaccinated during pregnancy and adults of the POX-MVA-045 study
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting total binding antibodies against the vaccinia virus in women vaccinated during pregnancy compared to adults of the POX-MVA-045 study at baseline and all blood collection time points after the second dose.
Time frame: Baseline to 13 months postpartum
Binding antibody reponse in women vaccinated in the immediate postpartum period and adults of the POX-MVA-045 study
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting total binding antibodies against the vaccinia virus in women vaccinated in the immediate postpartum period compared to adults of the POX-MVA-045 study at baseline and all blood collection time points after the second dose.
Time frame: Throughout the trial period; from first vaccination to 13 months postpartum
Binding antibody reponse in women vaccinated during pregnancy and women vaccinated in the immediate postpartum
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting total binding antibodies against the vaccinia virus in women vaccinated during pregnancy compared to women vaccinated in the immediate postpartum period, at baseline, 2 weeks after the second dose, delivery, 6 weeks (if different from 2 weeks after the second dose), 12 weeks, 6 months and 13 months after delivery.
Time frame: Delivery to 13 months postpartum
Safety and reactogenicity of the MVA-BN in women vaccinated in the immediate postpartum and adults of the POX-MVA-045 study
To assess the safety and reactogenicity of the MVA-BN standard regimen administered to women in the immediate postpartum compared to adults (POX-MVA-045).
Time frame: Throughout the trial period; from first vaccination to 13 months postpartum.
Safety and reactogenicity of the MVA-BN in women vaccinated during pregnancy and women vaccinated in the immediate postpartum
To assess the safety and reactogenicity of the MVA-BN standard regimen administered in pregnant women compared to women in the immediate postpartum period.
Time frame: Throughout the trial period; from enrolment to 1 year after second dose
Correlation between maternal IgG in serum and IgA antibody levels in breastmilk
To explore whether there is a correlation between maternal IgG antibody levels against the vaccinia and mpox virus in serum and maternal IgA antibody levels against the vaccinia and mpox virus in breastmilk of women vaccinated during pregnancy or women vaccinated in the postpartum at delivery and at 6 weeks, 12 weeks, and 6 months, 13 months postpartum.
Time frame: From delivery to 13 months postpartum
Correlation between maternal IgG antibody levels in serum and breastmilk in the first 12 weeks postpartum
To explore whether there is a correlation between maternal IgG antibody levels against the vaccinia and mpox virus in serum and breastmilk of women vaccinated during pregnancy or women vaccinated in the postpartum at 6 and 12 weeks postpartum.
Time frame: 6 weeks and 12 weeks postpartum
Correlation between maternal IgA and IgG antibody levels in breastmilk
To explore whether there is a correlation of maternal IgA and IgG antibodies against the vaccinia and mpox virus in breastmilk in women vaccinated during pregnancy or women vaccinated in the postpartum at 6 weeks and 12 weeks.
Time frame: Baseline to 13 months postpartum
Immunogenicity of MVA-BN used as PEP in women exposed during pregnancy
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting neutralising antibodies against the vaccinia virus in PEP women vaccinated during pregnancy compared to women not exposed to mpox and vaccinated during pregnancy at baseline, 2 weeks after the second dose, and at 6 weeks, 12 weeks, 6 months and 13 months after delivery.
Time frame: Baseline to 13 months postpartum
Binding antibody response in PEP women vaccinated during pregnancy versus non-exposed women
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting total binding antibodies against the vaccinia virus in PEP women vaccinated during pregnancy compared to women not exposed to mpox and vaccinated during pregnancy at baseline, 2 weeks after the second dose, and at and at 6 weeks, 12 weeks, 6 months and 13 months after delivery.
Time frame: Delivery to 13 months postpartum
safety and reactogenicity of the MVA-BN in PEP women vaccinated during pregnancy
To assess the safety and reactogenicity of the MVA-BN standard regimen, administered SC in PEP women vaccinated during pregnancy compared to women not exposed to mpox and vaccinated during pregnancy.
Time frame: Throughout the trial period; from first vaccination to 13 months postpartum.
Safety in newborns/infants born to mothers vaccinated with PEP
To assess safety in newborns/infants born to mothers vaccinated with PEP compared to those born to mothers vaccinated during pregnancy not exposed to mpox.
Time frame: From delivery to 13 months postpartum
Pregnancy, foetal and neonatal outcomes
To describe pregnancy and foetal, and neonatal outcomes in children born to PEP women compared to women not exposed to mpox and vaccinated during pregnancy (control) and, if possible, the outcomes of pregnancy surveillance in Boende for the duration of the study.
Time frame: Baseline to 13 months postpartum
Demographic and obstetric variables impacting infant antibodies
To explore which demographic and obstetric variables (e.g. age, sex, gestational age at vaccination during pregnancy, malaria exposure, HIV status, malnutrition, etc.) impact the neutralising, total binding antibody, and IgG binding (as applicable) antibody response against the vaccine antigen in the serum of (exposed) pregnant and postpartum women and their newborn/infant.
Time frame: From enrolment to 13 months postpartum
Neutralising antibody response in a subset of women vaccinated during pregnancy and during the immediate postpartum
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting neutralising antibodies against the monkeypox and vaccinia virus in a subset (10%) of women vaccinated during pregnancy compared to a subset (10%) of women vaccinated in the immediate postpartum period at baseline, 2 weeks after the second dose, at delivery, and 6 weeks (if different from 2 weeks after the second dose), 12 weeks, 6 months and 13 months after delivery.
Time frame: Baseline to 13 months postpartum
Total IgG Response Against Multiple MPXV Antigens with Standard and Half-Dose Regimens.
To assess the immunogenicity of the MVA-BN standard regimen, administered SC, in eliciting Total IgG in serum with multiple MPXV specific antigens (B6R, B2R, E8L, M1R, A35, H3L) in a subset (10%) of women vaccinated during pregnancy compared to a subset (10%) of women vaccinated in the immediate postpartum period at baseline, 2 weeks after the second dose, at delivery, and 6 weeks (if different from 2 weeks after the second dose), 12 weeks, 6 months and 13 months after delivery.
Time frame: Baseline to 13 months postpartum
Demographic and obstetric variables impacting cord blood antibodies
To explore which demographic and obstetric variables (e.g. age, sex, gestational age at vaccination during pregnancy, malaria exposure, HIV-status, malnutrition, etc.) impact the presence of maternally derived neutralising, total binding, and IgG binding antibodies against the vaccine antigen in cord blood.
Time frame: Cord blood collected at delivery
Demographic and obstetric variables impacting breastmilk antibodies
To explore which demographic and obstetric variables (e.g. age, sex, gestational age at vaccination during pregnancy, malaria exposure, malnutrition, etc.) impact the presence of maternally derived neutralising, total binding, and IgG and IgA binding antibodies against the vaccine antigen in breastmilk.
Time frame: Baseline to 13 months postpartum
Impact of demographic variables on presence of maternally derived antibodies in infant's blood sample
To explore which demographic and obstetric variables (e.g. age, sex, gestational age at vaccination during pregnancy, malaria exposure, malnutrition, etc.) impact the presence of maternally derived neutralising, total binding, and IgG and IgA binding antibodies against the vaccine antigen in infant's blood samples.
Time frame: Baseline to 13 months postpartum
Plan to share: No
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Jean-Pierre Van geertruyden