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| Name | Class |
|---|---|
| Institut National de Recherche Biomédicale (INRB). Kinshasa, Democratic Republic of Congo | UNKNOWN |
| Programme Elargi de Vaccination de République Démocratique du Congo | UNKNOWN |
| National Institute of Public Health of the Democratic Republic of the Congo |
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The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of a routine mpox vaccination campaign in Kinshasa, Democratic Republic of the Congo (DRC). Participants will be followed up at multiple time points after vaccination in order to assess the kinetics and durability of the immune response by collection of blood samples. It is planned to include approximately 150 participants vaccinated with MVA-BN and 150 participants vaccinated with LC16m8.
The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of a routine mpox vaccination campaign in Kinshasa, Democratic Republic of the Congo (DRC). Participants will be followed up at multiple time points after vaccination in order to assess the kinetics and durability of the immune response. It is planned to include approximately 150 participants vaccinated with MVA-BN and 150 participants vaccinated with LC16m8. Participants will be followed up in the clinical trial for a period of 24 months with 6 visits: visit 1 (day 0), visit 2 (day 0 + 28 days), visit 3 (day 0 + 59 days), visit 4 (day 0 + 8 months), visit 5 (day 0 + 16 months) and visit 6 (day 0 + 24 months). The study intervention consists of blood samples. At each visit, 10 mL of blood will be collected, and additional blood samples (20 mL per visit) will be taken from a subgroup of participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVA-BN or LC16m8 vaccinated | Other | Participants vaccinated with MVA-BN or LC16m8 vaccine during the national vaccination campaign |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample collection | Procedure | 10 mL of blood will be collected at every visit and additional 20 mL blood samples will be taken from a subgroup of participants at every visit. |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the seroconversion rate for neutralising antibodies against the mpox virus (MPXV) 28 days after administration of an mpox vaccine (MVA-BN or LC16m8) | Seroconversion 28 days after administration of an mpox vaccine, defined as the appearance of an MPXV neutralizing antibody titer (NT50) greater than or equal to the limit of detection in participants who were seronegative at baseline, or at least a two-fold increase in the antibody titer compared to baseline (Day 0) in participants who were seropositive at inclusion | Day 28 after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the positivity rate for neutralizing antibodies against MPXV 59 days and 8 months after administration of an mpox vaccine (MVA-BN or LC16m8). | Positivity rate 59 days and 8 months after administration of an mpox vaccine (MVA-BN or LC16m8), defined as the appearance of an MPXV neutralizing antibody titer (NT50) greater than or equal to the limit of detection for participants who were initially seronegative, or by a two-fold increase or more in antibody titer compared with the value at Day 0 in participants who were seropositive at enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine, in a subgroup, the T-cell response induced by the MVA-BN or LC16m8 vaccine at Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24. | Number or frequency of MPXV-specific T lymphocytes at Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24. | Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 |
Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Convivial Kasa-Vubu | Kinshasa | Democratic Republic of the Congo | ||||
| Kinoise |
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| Day 59 and Month 8 |
| To analyze the longitudinal evolution of neutralizing antibody titers against MPXV between Day 0, Day 28, Day 59, and Month 8 after administration of an mpox vaccine (MVA-BN or LC16m8). | Neutralizing antibody titers against MPXV measured at Day 0, Day 28, Day 59, and Month 8 after administration of an mpox vaccine (MVA-BN or LC16m8). | Day 0, Day 28, Day 59 and Month 8 |
| To estimate the positivity rate for binding antibodies (IgG) against MPXV at all sampling time points: Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8). | Positivity rate at Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8). The positivity rate is defined by the appearance of median fluorescence intensity (MFI) values greater than the limit of detection for participants who were initially seronegative, or by more than a two-fold increase in antibody titer compared with the value at Day 0 for participants who were seropositive at baseline. | Day 0, Day 28, Day 59, Month 8, Month 16 and Month 24 |
| To analyze the longitudinal evolution of binding antibody (IgG) titers against MPXV between Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8). | Binding antibody (IgG) titers against MPXV measured at Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8), compared with binding antibody (IgG) titers at Day 0. | Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 |
| To identify factors associated with weak immune responses, measured by the seroconversion rate of neutralizing antibodies at Day 0, Day 28, Day 59, and Month 8 after administration of an mpox vaccine (MVA-BN or LC16m8). | Seroconversion at Day 0, Day 28, Day 59, and Month 8 after administration of an mpox vaccine (MVA-BN or LC16m8). The association between risk factors and neutralizing antibody titers will be assessed using logistic regression (or mixed-effects logistic regression for the longitudinal analysis). | Day 0, Day 28, Day 59, and Month 8 |
| To identify factors associated with weak immune responses, measured by the seroconversion rate of binding antibodies (IgG) at Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8). | Seroconversion at Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8). The association between risk factors and binding antibody (IgG) titers will be assessed using logistic regression (or mixed-effects logistic regression for the longitudinal analysis). | Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 |
| To evaluate the tolerability of MVA-BN and LC16m8 vaccines in terms of solicited symptoms occurring up to 28 days after vaccination. | The frequency of solicited local symptoms (pain, redness, swelling, induration, itching, or a distinct mark [only for the LC16m8 vaccine] at the injection site) and solicited systemic symptoms (headache, fatigue, nausea, vomiting, generalized muscle pain, chills, and/or fever greater than or equal to 38.0°C) up to Day 28 after vaccination. | Day 28 |
| To document post-vaccination mpox virus infections after administration of an mpox vaccine (MVA-BN or LC16m8). | Number of post-vaccination mpox infections. Post-vaccination mpox infections are defined as any laboratory-confirmed mpox infection occurring after vaccination (assessed anamnesticly). | Month 24 |
| To compare the seroconversion rates of neutralizing antibodies and binding antibodies (IgG) against MPXV, and of vaccine-induced T lymphocytes, between participants vaccinated with MVA-BN versus LC16m8. |
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| Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 |
| To compare the seroconversion rates of neutralizing antibodies and binding antibodies (IgG) against MPXV, and of vaccine-induced T lymphocytes, between naïve participants and those with a history of smallpox/mpox vaccination or prior mpox infection. |
| Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 |
| Kinshasa |
| Democratic Republic of the Congo |
| Kokolo | Kinshasa | Democratic Republic of the Congo |
| ID | Term |
|---|---|
| D045908 | Mpox, Monkeypox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018419 | Primate Diseases |
| D000820 | Animal Diseases |
| D012376 | Rodent Diseases |
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