HPV InfectionPhase 1NCT05829629
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
A Phase 1 study testing FluBHPVE6E7 in people with HPV Infection and HPV-Related Cervical Carcinoma, run by BlueSky Immunotherapies GmbH at 1 site in Slovakia.
Trial summary
BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- HPV Infection, HPV-Related Cervical Carcinoma
- What is being tested?
- FluBHPVE6E7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSlovakia
- Study dates
- 12 Sep 2023to Nov 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females, 18-49 years of age with HPV16 infection and cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1)
- HPV16 infection has been confirmed at least twice by a validated HPV test separated by at least 3 months
- Satisfactory colposcopy
- No clinically significant out of range haematological, renal or hepatic laboratory tests
- Normal screening ECG or screening ECG with no clinically significant findings, as judged by the investigator
- Negative serum pregnancy test at screening
- Agree to use a reliable form of contraception during the whole study period.
- Provides written informed consent
Who cannot join
- Any vaccination within 6 weeks of day 0
- Active significant viral infections including influenza, CMV, and EBV within 30 days of receiving study treatment
- Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states
- Current Bacterial Vaginosis (BV) infection
- Current high-grade cervical intraepithelial neoplasia (CIN2/3)
- Prior history of or current malignancy, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), atypical glandular cells (AGC), adenocarcinoma in situ (AIS) or any suspicion of either micro-invasive or invasive disease
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- Pregnancy, breastfeeding
- Influenza-like illness (ILI) within 3 months of day 0
- Known hypersensitivity to oseltamivir or any of its components
- Any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the cervix
- Current pelvic inflammatory disease, cervicitis, or other gynaecological infection as per colposcopy and clinical examination
- Serious, concomitant disorder, including active systemic infection requiring treatment
- Presence of acute or chronic bleeding or clotting disorder, or use of blood thinners within 2 weeks of day 0
- A proven or suspected autoimmune disease
- Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs, and biologic disease modifying drugs. Any immunosuppressive agents containing corticosteroids or monoclonal antibodies specific for the treatment of obstructive airway, ear or vestibular diseases are permissible.
- Acute or history of Herpes genitalis
- Prior major surgery within 4 weeks of day 0
- Administration of any blood product within 3 months of enrolment
- Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease
- Any current or history of neurological disease including history of seizures
- Participation in another experimental protocol/use of investigational drug during the prior two months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
Univerzitná nemocnica Bratislava
Bratislava, 82606
00421 2 48234 ext. 111
About this study
Official title: Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women with NILM, ASC-US, LSIL or Low-grade CIN
BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).
Read the detailed description
FluBHPVE6E7 is an influenza virus vector that was modified on several levels to be used as an immunotherapeutic agent against human papillomavirus (HPV) infections, and precancers and cancers induced by HPV.
Study BS-02 investigates the safety, tolerability and immunogenicity of FluBHPVE6E7 in HPV-16 infected women.
FluBHPVE6E7 is administered three times at two dose levels. The first dose is administered into the cervix, subsequent doses are administered intramuscularly.
- Conditions
- HPV Infection, HPV-Related Cervical Carcinoma
- Being tested
- FluBHPVE6E7, Placebo
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluBHPVE6E7Biological
Intracervical administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule
PlaceboDrug
Intracervical administration for first dose followed by intramuscular administration for subsequent doses at determined schedule
| Study group | Role | What they receive |
|---|---|---|
| FluBHPVE6E7 | Experimental | intracervical and intramuscular 0.5 ml per dose 3 doses (12 weeks) Receives: Biological: FluBHPVE6E7 |
| Placebo | Placebo comparator | intracervical and intramuscular 0.5 ml per dose 3 doses (12 weeks) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events (AEs)
The severity of the adverse event is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: 7 days
Secondary outcomes (8)
Induction of HPV-specific T-cell response following FluBHPVE6E7 administration
To evaluate the induction of HPV16 E6- and E7-specific T-cells (%) by IFN-gamma ELISPOT analysis.
Measured: 16 weeks
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
To evaluate the induction of systemic vector-specific antibodies by HAI assay.
Measured: 16 weeks
Local HPV clearance
To evaluate the status of HPV-16 infection by HPV test (yes or no).
Measured: 16 weeks
Cervical cytology
To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System.
Measured: 16 weeks
Biodistribution: Detection of FluBHPVE6E7 in blood samples
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in blood samples by RT-qPCR (copies per ml blood).
Measured: 16 weeks
Biodistribution: Detection of FluBHPVE6E7 in saliva
To evaluate the presence of FluBHPVE6E7 by qualitative real-time PCR assay specific for influenza B virus (positive or negative).
Measured: 16 weeks
Viral shedding: Detection of FluBHPVE6E7 in vaginal secretion samples
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in vaginal secretion samples by RT-qPCR (copies per sample).
Measured: 16 weeks
Number of participants with adverse events (type, frequency, severity).
To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start12 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlueSky Immunotherapies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829629
- Sponsor's protocol ID
- BS-02
- Status last verified
- Feb 2025
- First submitted
- 11 Apr 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women with NILM, ASC-US, LSIL or Low-grade CIN
- ClinicalTrials.gov ID
- NCT05829629
- Acronym / sponsor ID
- BS-02
- Conditions
- HPV Infection, HPV-Related Cervical Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BlueSky Immunotherapies GmbHIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 26 Apr 2023 (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.
BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).
Detailed description
FluBHPVE6E7 is an influenza virus vector that was modified on several levels to be used as an immunotherapeutic agent against human papillomavirus (HPV) infections, and precancers and cancers induced by HPV.
Study BS-02 investigates the safety, tolerability and immunogenicity of FluBHPVE6E7 in HPV-16 infected women.
FluBHPVE6E7 is administered three times at two dose levels. The first dose is administered into the cervix, subsequent doses are administered intramuscularly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FluBHPVE6E7 | Experimental | Biological: FluBHPVE6E7intracervical and intramuscular 0.5 ml per dose 3 doses (12 weeks) |
| Placebo | Placebo comparator | Drug: Placebointracervical and intramuscular 0.5 ml per dose 3 doses (12 weeks) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Females, 18-49 years of age with HPV16 infection and cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1)
- HPV16 infection has been confirmed at least twice by a validated HPV test separated by at least 3 months
- Satisfactory colposcopy
- No clinically significant out of range haematological, renal or hepatic laboratory tests
- Normal screening ECG or screening ECG with no clinically significant findings, as judged by the investigator
Key exclusion criteria (21 listed)
- Any vaccination within 6 weeks of day 0
- Active significant viral infections including influenza, CMV, and EBV within 30 days of receiving study treatment
- Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states
- Current Bacterial Vaginosis (BV) infection
- Current high-grade cervical intraepithelial neoplasia (CIN2/3)
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 |
|---|---|---|
| FluBHPVE6E7Intracervical administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule | Biological | FluBHPVE6E7 |
| PlaceboIntracervical administration for first dose followed by intramuscular administration for subsequent doses at determined schedule | Drug | Placebo |
Primary outcome
Frequency and severity of adverse events (AEs)
Time frame: 7 days
The severity of the adverse event is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
8 secondary outcomes
Induction of HPV-specific T-cell response following FluBHPVE6E7 administration
Time frame: 16 weeks
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
Time frame: 16 weeks
Local HPV clearance
Time frame: 16 weeks
Cervical cytology
Time frame: 16 weeks
Biodistribution: Detection of FluBHPVE6E7 in blood samples
Time frame: 16 weeks
Biodistribution: Detection of FluBHPVE6E7 in saliva
Time frame: 16 weeks
Viral shedding: Detection of FluBHPVE6E7 in vaginal secretion samples
Time frame: 16 weeks
Number of participants with adverse events (type, frequency, severity).
Time frame: 16 weeks
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 14 Feb 2025.
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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.
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 FluBHPVE6E7 in people with HPV Infection and HPV-Related Cervical Carcinoma, run by BlueSky Immunotherapies GmbH at 1 site in Slovakia.
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 8 inclusion and 21 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 14 Feb 2025. 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 Slovakia. 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. Some participants in this study may receive a placebo. 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?
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 BlueSky Clinical Operations (+43 664 1888028, clinical@bluesky-itx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of adverse events (AEs) (time frame: 7 days). 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 14 Feb 2025.