36 Participants Needed

HER2 Vaccine for Breast Cancer

NS
Overseen ByNiraj Shah
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pravin T.P Kaumaya
Must be taking: HER2 targeted therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require corticosteroids or other immunosuppressive drugs, or if you are receiving or planning to receive adjuvant CDK4/6 inhibitor therapy.

What data supports the effectiveness of the HER2 Vaccine treatment for breast cancer?

Research shows that HER2 vaccines can trigger immune responses in patients, and early studies suggest they might help reduce cancer recurrence when given to patients at high risk. However, more evidence is needed to confirm their effectiveness in later stages of clinical trials.12345

Is the HER2 vaccine safe for humans?

The HER2 vaccine has been tested in early-stage clinical trials and was generally well tolerated, with few late toxicities reported. In a Phase I trial, patients receiving the vaccine showed an acceptable safety profile, and most patients were still alive and disease-free after five years.15678

How is the HER2 Vaccine treatment different from other breast cancer treatments?

The HER2 Vaccine is unique because it aims to stimulate the body's immune system to target and attack HER2-positive breast cancer cells, unlike traditional treatments that use monoclonal antibodies or kinase inhibitors. This vaccine approach is designed to be safe by avoiding the oncogenic activity associated with HER2, and it can potentially offer a new way to treat patients who do not respond to existing therapies.12578

What is the purpose of this trial?

The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.

Research Team

PK

Pravin Kaumaya, PhD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for women over 18 with HER2 positive breast cancer who've finished chemo or radiation at least a month ago and had six months of HER2 therapy. They must not be pregnant, have serious autoimmune diseases, active infections needing antibiotics, other cancers, or heart/lung issues. A negative pregnancy test and agreement to use contraception are required.

Inclusion Criteria

Women of childbearing potential must have a negative serum pregnancy test within 14 days of protocol registration and agree to use effective contraception throughout the study and for 6 months after the last study treatment
Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864
My breast cancer is confirmed to be HER2 positive.
See 7 more

Exclusion Criteria

Immediate hypersensitivity skin test positive to specific antigens
Active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome
Developed anaphylactic responses to other vaccines
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational HER2 vaccine intramuscularly every 21 days for three doses, with a booster at 6 months

9 weeks
3 visits (in-person) for initial doses, 1 visit (in-person) for booster

Follow-up

Participants are monitored for immune response and safety through ELISA quantification and adverse event assessment

9 weeks
Regular intervals (in-person)

Long-term follow-up

Participants may be monitored for long-term safety and immune response

6 months

Treatment Details

Interventions

  • HER2 Vaccine
Trial Overview The study is testing an investigational vaccine designed to stimulate the immune system to combat breast cancer in patients with high-risk disease characteristics after standard treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: HER2 Vaccine ArmExperimental Treatment1 Intervention
MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines are combined in 1.5 mg doses of each peptide into a 3.0 mg total dose. This is administered intramuscularly in the gluteus maximus once every 21 days for three doses, in alternating sides (i.e. left-\>right-\>left), with a booster administered at 6 months.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pravin T.P Kaumaya

Lead Sponsor

Trials
1
Recruited
40+

Findings from Research

The E75 vaccine demonstrated significant effectiveness in improving immune responses and clinical outcomes, such as reduced recurrence rates and increased disease-free survival in breast cancer patients, with minimal side effects reported.
The GP2 vaccine also showed promise in eliciting immune responses, particularly in increasing CD8+ T-cell numbers, but further clinical trials are necessary to establish its efficacy compared to the E75 vaccine.
Application of HER2 peptide vaccines in patients with breast cancer: a systematic review and meta-analysis.You, Z., Zhou, W., Weng, J., et al.[2021]
The AE37 vaccine, which targets the HER-2/neu protein in breast cancer, has been shown to be safe and effective in generating long-lasting immune responses in patients, regardless of their HER-2/neu expression levels.
Early clinical trials indicate that the AE37 vaccine may help prevent breast cancer recurrence, highlighting its potential as a promising immunotherapy option.
AE37: a novel T-cell-eliciting vaccine for breast cancer.Sears, AK., Perez, SA., Clifton, GT., et al.[2014]
A phase I trial involving 22 women with HER2+ breast cancer showed that a degenerate HER2 epitope-based vaccine was well tolerated and successfully induced strong T-cell immunity in 68% to 88% of patients, with 90% generating T cells that recognized HER2 antigens.
The vaccine not only enhanced T-cell responses but also increased HER2-specific antibodies, and the immunity appeared to be sustained for at least 2 years, suggesting potential for improved outcomes when combined with trastuzumab treatment.
Rapid Generation of Sustainable HER2-specific T-cell Immunity in Patients with HER2 Breast Cancer using a Degenerate HLA Class II Epitope Vaccine.Knutson, KL., Block, MS., Norton, N., et al.[2021]

References

Application of HER2 peptide vaccines in patients with breast cancer: a systematic review and meta-analysis. [2021]
AE37: a novel T-cell-eliciting vaccine for breast cancer. [2014]
Rapid Generation of Sustainable HER2-specific T-cell Immunity in Patients with HER2 Breast Cancer using a Degenerate HLA Class II Epitope Vaccine. [2021]
HER2/neu vaccines in breast cancer. [2016]
The clinical development of vaccines for HER2+ breast cancer: Current landscape and future perspectives. [2017]
A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors. [2022]
An adenoviral vaccine encoding full-length inactivated human Her2 exhibits potent immunogenicty and enhanced therapeutic efficacy without oncogenicity. [2021]
Phase 1 clinical trial of HER2-specific immunotherapy with concomitant HER2 kinase inhibition [corrected]. [2023]
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