MonkeypoxNCT05562323
Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
An observational study of Monkeypox, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 3 sites in Spain.
Trial summary
This observational study has been designed to characterize humoral and cellular immune responses after vaccination against monkeypox (MKP) in HIV positive and negative individuals at high risk of MKP infection during the vaccination campaign in the current monkeypox outbreak. Read more about this study
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
- All sexes
- Adult, Older adult
Study population: 100 individuals who have been/will be vaccinated against MKP as pre-exposuire profilaxis following the National Vaccination Plan (40-50/50-60% of HIV negative and HIV positive individuals)
Who may be able to join
- Adult individuals of ≥18 years old.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
- Has understood the information provided and capable of giving informed consent.
Who cannot join
- 1. Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Bea Mothe, MD,PhD
Susana Benet, MD,PhD
- Recruiting
BCN Checkpoint
Barcelona, Barcelona, 08015
Ángel Rivero Calaf, MD,PhD, arivero@lluita.org
- Not yet recruiting
VALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes
Barcelona, Barcelona, 08035
Vicente Descalzo Jorro, MD,PhD
About this study
This observational study has been designed to characterize humoral and cellular immune responses after vaccination against monkeypox (MKP) in HIV positive and negative individuals at high risk of MKP infection during the vaccination campaign in the current monkeypox outbreak.
Read the detailed description
Of the 23,837 cases of monkeypox reported in the European Region of the WHO, 7.037 have been identified in Spain, according to the National Epidemiological Surveillance Network (RENAVE). Most of diagnosed individuals are men born in Spain, being nearly 40% HIV positive. The clinical evolution was satisfactory, although 3-7% of cases required hospitalization.
Given the limited number of available doses of the MVA-BN vaccine, it has been recently approved its use as a single intradermal dose. However, this posology can be more reactogenic than subcutaneous injection and there is limited data on its immunogenicity and effectiveness in people living with HIV (PLWH), which account for about half of the monkeypox cases in the current outbreak.
The present observational study has been designed to investigate the humoral and cellular immune responses following monkeypox vaccination in PLWH.
- Conditions
- Monkeypox
- Keywords
- Monkeypox vaccine, Immune responses, HIV
- Medical subject headings
- Mpox, Monkeypox
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 |
|---|---|---|
| MKP vaccination for pre-exposure prophylaxis (HIV positive) | HIV positive individuals who receive MKP vaccination for pre-exposure prophylaxis | |
| MKP vaccination for pre-exposure prophylaxis (seronegative individuals) | HIV seronegative individuals who receive MKP vaccination for pre-exposure prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with detectable anti-orthopox antibodies
Proportion of participants with detectable anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination
Measured: Between day 29 - 90
Quantification of anti-orthopox antibodies
Quantification of anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination
Measured: Between day 29 - 90
Secondary outcomes (4)
Changes of the immunogenicity after the first vaccine dose
The geometric mean fold rise (GMFR) in anti-orthopox antibody titers from baseline to Day 29-90 and 150-180 after the first dose of MVA-BN and to 29-90 and 150-180 after the second dose (if applicable)
Measured: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
To compare immunogenicity between HIV negative and HIV positive individuals
To compare the GMFR between HIV negative and HIV positive individuals
Measured: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
Neutralization capacity of anti-orthopox antibodies
Neutralization titers measured as the reciprocal dilution inhibiting 50% of the infection (ID50) will be reported using a live virus assay (VNA) to measure cytopathic effect in Vero E6 cells after the first dose of MVA-BN.
Measured: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
To compare neutralization capacity between HIV negative and HIV positive individuals
To compare ID50 between HIV negative and HIV positive individuals
Measured: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start14 Sep 2022
- Primary completion1 Jul 2026
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MonkeypoxStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- IrsiCaixa, BCN Checkpoint
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562323
- Sponsor's protocol ID
- MoVIHvax
- Status last verified
- Jul 2026
- First submitted
- 27 Sep 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05562323
- Acronym / sponsor ID
- MoVIHvax
- Conditions
- Monkeypox
- Keywords
- Monkeypox vaccine, Immune responses, HIV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- IrsiCaixa, BCN Checkpoint
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 30 Sep 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.
This observational study has been designed to characterize humoral and cellular immune responses after vaccination against monkeypox (MKP) in HIV positive and negative individuals at high risk of MKP infection during the vaccination campaign in the current monkeypox outbreak.
Detailed description
Of the 23,837 cases of monkeypox reported in the European Region of the WHO, 7.037 have been identified in Spain, according to the National Epidemiological Surveillance Network (RENAVE). Most of diagnosed individuals are men born in Spain, being nearly 40% HIV positive. The clinical evolution was satisfactory, although 3-7% of cases required hospitalization.
Given the limited number of available doses of the MVA-BN vaccine, it has been recently approved its use as a single intradermal dose. However, this posology can be more reactogenic than subcutaneous injection and there is limited data on its immunogenicity and effectiveness in people living with HIV (PLWH), which account for about half of the monkeypox cases in the current outbreak.
The present observational study has been designed to investigate the humoral and cellular immune responses following monkeypox vaccination in PLWH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MKP vaccination for pre-exposure prophylaxis (HIV positive) | – | –HIV positive individuals who receive MKP vaccination for pre-exposure prophylaxis |
| MKP vaccination for pre-exposure prophylaxis (seronegative individuals) | – | –HIV seronegative individuals who receive MKP vaccination for pre-exposure prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 100 individuals who have been/will be vaccinated against MKP as pre-exposuire profilaxis following the National Vaccination Plan (40-50/50-60% of HIV negative and HIV positive individuals)
Key inclusion criteria (3 listed)
- Adult individuals of ≥18 years old.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
- Has understood the information provided and capable of giving informed consent.
Key exclusion criteria (1 listed)
- 1. Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.
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
Proportion of participants with detectable anti-orthopox antibodies
Time frame: Between day 29 - 90
Proportion of participants with detectable anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination
Quantification of anti-orthopox antibodies
Time frame: Between day 29 - 90
Quantification of anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination
4 secondary outcomes
Changes of the immunogenicity after the first vaccine dose
Time frame: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
To compare immunogenicity between HIV negative and HIV positive individuals
Time frame: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
Neutralization capacity of anti-orthopox antibodies
Time frame: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
To compare neutralization capacity between HIV negative and HIV positive individuals
Time frame: Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 3 sites in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Mothe, PhD, MD (676142408, bmothe@irsicaixa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with detectable anti-orthopox antibodies (time frame: Between day 29 - 90). The study lists 2 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 7 Jul 2026.