Crimean Congo Hemorrhagic FeverPhase 1CCHF-NP-1NCT06684431
Study to Evaluate Safety and Immunogenicity of DNA Vaccine N-pVAX1 Against Crimean Congo Hemorrhagic Fever
A Phase 1 study testing N-pVAX1 in people with Crimean Congo Hemorrhagic Fever, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Crimean Congo Hemorrhagic Fever
- What is being tested?
- N-pVAX1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 12 Nov 2024to 17 Mar 2026
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between the ages of 18 and 60 years (at the time of consent).
- Healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments.
- No clinically significant laboratory abnormalities as determined by the investigator at screening.
- Note: one retest of lab tests is allowed within the screening window.
- Negative HIV 1/2 antibody/antigen test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening.
- Participant with a body mass index (BMI) 20-30.0 kg/m2.
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- Provide written informed consent before initiation of any study procedures.
- A female participant is eligible for this study if she is one of the following:
- of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year)
- of childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 3 months after last vaccination.
- Highly effective methods of contraception include one or more of the following:
- male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject;
- hormonal (oral, intravaginal, transdermal, implantable or injectable)
- an intrauterine hormone-releasing system (IUS)
- an intrauterine device (IUD) with a documented failure rate of < 1%.
- A female participant is eligible if she is willing to abstain from donating oocyte and a male participant if he is willing to abstain from donating sperm from the screening visit up to 3 months after last vaccination.
- A male participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 3 months after last vaccination except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception.
- Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.
Who cannot join
- History of presence of pulmonary disorders (chronic obstructive pulmonary lung disease etc) or asthma (exception of allergic asthma, which is allowed).
- History or presence of thrombocytopenia and/or bleeding disorders.
- A positive serum pregnancy test at screening or urine pregnancy test prior to study injection, women who are planning to become pregnant during the study, or women who are breastfeeding.
- Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune, central nervous system or neurological diseases.
- Use of immunosuppressive drugs as e.g. corticosteroids (excluding topical preparations and inhalers) within 3 months prior to vaccination or 6 months for chemotherapies and all along the study.
- Vaccination within 2 weeks prior to vaccination or planning to receive a licensed vaccine before month 3 (e.g. inactivated influenza vaccine).
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- History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of known or suspected allergic reaction likely to be exacerbated by any component of the Investigational vaccine.
- Participation in another investigational clinical study within four weeks before the screening visit or planned before the study completion.
- Subjects with confirmed or suspected immunodeficiency.
- Any condition that in the opinion of the principal investigator (PI) would jeopardize the safety or rights of a person participating in the trial or would render the person unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Phase I Unit, Karolinska University Hospital
Stockholm, Stockholm County, 17176
About this study
Official title: A Phase I Study to Evaluate Safety and Immunogenicity of DNA Vaccine N-pVAX1 Against Crimean Congo Hemorrhagic Fever
This First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
Read the detailed description
This First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
The study vaccine dose is planned to be staggered, starting with the low-dose group (0.45 mg), followed by the mid-dose group (0.9 mg), and finally the high-dose group (1.8 mg). In total 15 healthy volunteers at the ages of 18-60 will be enrolled.
Primary objective:
- The primary objective of this study is to assess the safety and reactogenicity of the investigational vaccine N-pVAX1 delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
The secondary objectives:
- To investigate the humoral immune response to the investigational vaccine administered as three doses, by measuring CCHF nucleocapsid antibody levels.
Exploratory objective:
- To investigate in more detail the humoral response and to analyze the cellular immune response to the investigational vaccine.
Trial participants will be followed-up for local and systemic adverse reactions throughout the study period. Blood samples to measure presence of antibody levels to the vaccine components and cellular immunity will be taken at Day 14 and 28 post first and second vaccine dose and at Day 14 and 3 months post last vaccine dose.
- Conditions
- Crimean Congo Hemorrhagic Fever
- Being tested
- N-pVAX1
- Keywords
- N-pVAX1, Phase I, Dose-escalation
- Medical subject headings
- Hemorrhagic Fever, Crimean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-pVAX1Biological
Crimean Congo Hemorrhagic Fever Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | N-pVAX1 vaccine Receives: Biological: N-pVAX1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local reactions
Local reactions (pain at the injection site, redness, and swelling) for up to 7 days after each vaccine dose.
Measured: For up to 7 days after each vaccine dose
Visual analogue scale (VAS) score
Visual analogue scale (VAS) score to rate the level of pain experienced immediately (0 minutes), and after 5, 15, 30 and 60 minutes post-EP.
Measured: At vaccination (0 minutes), and after 5, 15, 30 and 60 minutes post-EP
Systemic events
Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for 7 days after each vaccine dose.
Measured: For 7 days after each vaccine dose
Unsolicited AEs
Unsolicited AEs from the first study dose to 28 days after the last vaccination.
Measured: From the first study dose to 28 days after the last vaccination
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs)
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) from the first study dose until the study end at 3 months after last vaccination.
Measured: From the first study dose until the study end at 3 months after last vaccination
Secondary outcomes (1)
Change in antibody levels to the CCHF nucleocapsid protein
Change from baseline sample (a two-fold increase in endpoint titer or a 50% increase in optical density at a 1:62, 1:125, 1:250, 1:500, or 1:1000 serum dilution) in antibody levels to the CCHF nucleocapsid protein by inhouse and/or commercial assays during the study period.
Measured: At Baseline, day 14 and 28 post vaccine dose and at 3 months post last vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start12 Nov 2024
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crimean Congo Hemorrhagic FeverStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose-escalation: first low-dose group (n=5), then mid-dose group (n=5), last high-dose group (n=5)
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matti Sällberg, Karolinska Institutet
- Investigators
- Soo Aleman, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684431
- Sponsor's protocol ID
- CCHF-NP-1
- Acronym
- CCHF-NP-1
- Status last verified
- Mar 2026
- First submitted
- 11 Nov 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate Safety and Immunogenicity of DNA Vaccine N-pVAX1 Against Crimean Congo Hemorrhagic Fever
- ClinicalTrials.gov ID
- NCT06684431
- Acronym / sponsor ID
- CCHF-NP-1 / CCHF-NP-1
- Conditions
- Crimean Congo Hemorrhagic Fever
- Keywords
- N-pVAX1, Phase I, Dose-escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 12 Nov 2024 (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 First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
Detailed description
This First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
The study vaccine dose is planned to be staggered, starting with the low-dose group (0.45 mg), followed by the mid-dose group (0.9 mg), and finally the high-dose group (1.8 mg). In total 15 healthy volunteers at the ages of 18-60 will be enrolled.
Primary objective:
- The primary objective of this study is to assess the safety and reactogenicity of the investigational vaccine N-pVAX1 delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
The secondary objectives:
- To investigate the humoral immune response to the investigational vaccine administered as three doses, by measuring CCHF nucleocapsid antibody levels.
Exploratory objective:
- To investigate in more detail the humoral response and to analyze the cellular immune response to the investigational vaccine.
Trial participants will be followed-up for local and systemic adverse reactions throughout the study period. Blood samples to measure presence of antibody levels to the vaccine components and cellular immunity will be taken at Day 14 and 28 post first and second vaccine dose and at Day 14 and 3 months post last vaccine dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose-escalation: first low-dose group (n=5), then mid-dose group (n=5), last high-dose group (n=5)
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: N-pVAX1N-pVAX1 vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Men and women between the ages of 18 and 60 years (at the time of consent).
- Healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments.
- No clinically significant laboratory abnormalities as determined by the investigator at screening.
- Note: one retest of lab tests is allowed within the screening window.
- Negative HIV 1/2 antibody/antigen test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening.
Key exclusion criteria (10 listed)
- History of presence of pulmonary disorders (chronic obstructive pulmonary lung disease etc) or asthma (exception of allergic asthma, which is allowed).
- History or presence of thrombocytopenia and/or bleeding disorders.
- A positive serum pregnancy test at screening or urine pregnancy test prior to study injection, women who are planning to become pregnant during the study, or women who are breastfeeding.
- Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune, central nervous system or neurological diseases.
- Use of immunosuppressive drugs as e.g. corticosteroids (excluding topical preparations and inhalers) within 3 months prior to vaccination or 6 months for chemotherapies and all along the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-pVAX1Crimean Congo Hemorrhagic Fever Vaccine | Biological | Vaccine |
Primary outcome
Local reactions
Time frame: For up to 7 days after each vaccine dose
Local reactions (pain at the injection site, redness, and swelling) for up to 7 days after each vaccine dose.
Visual analogue scale (VAS) score
Time frame: At vaccination (0 minutes), and after 5, 15, 30 and 60 minutes post-EP
Visual analogue scale (VAS) score to rate the level of pain experienced immediately (0 minutes), and after 5, 15, 30 and 60 minutes post-EP.
Systemic events
Time frame: For 7 days after each vaccine dose
Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for 7 days after each vaccine dose.
Unsolicited AEs
Time frame: From the first study dose to 28 days after the last vaccination
Unsolicited AEs from the first study dose to 28 days after the last vaccination.
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs)
Time frame: From the first study dose until the study end at 3 months after last vaccination
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) from the first study dose until the study end at 3 months after last vaccination.
1 secondary outcome
Change in antibody levels to the CCHF nucleocapsid protein
Time frame: At Baseline, day 14 and 28 post vaccine dose and at 3 months post last vaccine dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- 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.
Soo Aleman, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N-pVAX1 in people with Crimean Congo Hemorrhagic Fever, run by Karolinska Institutet at 1 site in Sweden.
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 18 inclusion and 10 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: finished, as of the sponsor's last update on 23 Mar 2026. 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 Sweden. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Local reactions (time frame: For up to 7 days after each vaccine dose). 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 23 Mar 2026.