VACSERA Clinical Research Center
VACSERA Clinical Research Center (VCRC)

A Regional Hub for High-Impact Vaccine Trials and Global Health Partnerships

VCRC is the specialized research arm of the Holding Company for Biological Products and Vaccines (VACSERA), the oldest producer of vaccines in the Middle East. Established in 2001 with a skilled and experienced team, capable of conducting clinical studies while maintaining full compliance with regulatory and quality standards, bridging the gap between advanced vaccine manufacturing and public health impact.

KEY STRATEGIC OBJECTIVE

Enabling High-Impact Clinical Research in Egypt & the Region

VCRC's Key Strategic Objective is to enable high-impact clinical research in Egypt by streamlining drug development, improving patient access to advanced care, developing regional research capacity for multinational trials, and integrating key stakeholders into a unified national clinical trials ecosystem.

Support high quality, evidence-generating, research activities at VACSERA

Enhance the body of knowledge on clinical research in and outside VACSERA

Support the development and sustainability of the clinical research industry in Egypt

OUR STRATEGIC VISION

Establishing a Regional Clinical Excellence Hub for Vaccine Validation & Phase IV Surveillance

Serving North Africa and driving continental health security in alignment with Africa CDC's 2040 vision.

Accelerate Vaccine Access

Host clinical trials for priority pipeline and accelerate regulatory registration.

Regional Hub Development

Serve as a training and validation center for North Africa to support Africa CDC’s 2040 vision.

Post-Marketing Excellence

Lead Phase IV studies to ensure long-term vaccine safety and efficacy across diverse African populations.

Location: Downtown Dokki, Giza — Easily accessible to target populations

Physical Infrastructure of CRC

Located downtown at Giza in Dokki district so it is easily accessible to the target population intended to be recruited for clinical trials, fully equipped with comprehensive diagnostic and patient care systems.

Dedicated patient examination clinics
Research pharmacy with temperature control & security
On-site laboratory services
Centrifuge and other lab equipment
Vital-signs monitoring equipment
Contracted ICU services
Secure document archiving
Private offices for staff and monitors
Internet and communication access
Integrated Electronic Health Records
CRC Physical Facilities

VCRC Clinical Examination & Monitoring Units

Compliant with International GCP Guidelines

OUR TEAM & INVESTIGATORS

Qualified Healthcare Professionals & Lead Investigators

VACSERA has got qualified healthcare professionals including: Operational, Regulatory & Quality site management team, along with Physicians, Nurses, and Research staff.

Lead Investigators Therapeutic Expertise

  • Vaccines
  • Allergy & Immunology
  • Diabetes
  • Blood Diseases (Hematology)
  • Cardiology
GCP COMPLIANCE & RECRUITMENT BENCHMARK
“Maintaining a 100% GCP compliance rate and are supported by a robust recruitment infrastructure that consistently delivers high-quality data and meets enrolment milestones ahead of schedule.”

— VCRC Quality & Clinical Operations

CORE COMPETENCIES & SERVICES

Comprehensive Suite of Services for Global Vaccine Developers

We offer a comprehensive suite of services for international vaccine developers and global health organizations.

Full-Scale Clinical Trial Management

Expertise in Phase III and Phase IV interventional clinical trials.

Mega-Trial Execution

Proven capacity to recruit hundreds of participants simultaneously with high retention rates.

Regulatory & Ethical Navigation

Streamlined processes for National Regulatory Authority (EDA) approvals, Supreme Council, and Ethics Committee (IRB) submissions.

Capacity Building Programs

For enhancing clinical research and drug development capabilities in Egypt.

Patient Recruitment & Retention

Targeted patient access backed by VACSERA's extensive healthcare network across Egypt.

Pharmacovigilance & Safety Reporting

Continuous safety monitoring and adverse event reporting compliant with international standards.

Bioequivalence (BE) Services

End-to-end bioequivalence study protocols, crossover designs, and clinical execution.

CLINICAL TRIAL PHASES & CAPABILITIES

Phase III • Phase IV • Interventional Clinical Trials

Phase IIIPhase IVInterventionalBioequivalence
COMPANY CAPABILITIES & ACCESS TO PATIENT POPULATION

Robust Infrastructure & Extensive Patient Populations

Comprehensive capabilities supporting recruitment, cold chain management, and clinical care across Egypt.

28+ Centers across 7 Governorates

VACSERA Vaccination Centers Network

Central center located in Dokki, Giza, connected to a nationwide network of over 28 vaccination centers across 7 governorates for seamless trial participant recruitment.

VACSERA Vaccination Centers Network
VACSERA Vaccination Centers Network
16,000+ Patients Annually

Blood Issuing Center & Transfusion Services

Central blood transfusion hub receiving more than 16,000 patients annually, providing biological fluids and hematological access for specialized clinical trials.

Blood Issuing Center & Transfusion Services
Blood Issuing Center & Transfusion Services
Blood Issuing Center & Transfusion Services
Specialized Nephrology Care

VACSERA Kidney Center

Dedicated nephrology and dialysis facility equipped with advanced renal care infrastructure, facilitating specialized clinical and biological investigations.

VACSERA Kidney Center
VACSERA Kidney Center
VACSERA Kidney Center
~6,000 Patients Annually

VACSERA Diabetes Center

High-volume specialized clinic receiving approximately 6,000 diabetic patients annually, offering extensive patient populations for endocrinology and metabolic studies.

VACSERA Diabetes Center
7 Multi-Disciplinary Specialties

VACSERA Medical Center Polyclinics

Comprehensive multidisciplinary clinics spanning Diabetes, Cardiology, Orthopedics, Pediatrics, Ophthalmology, Dentistry, and Gynecology.

VACSERA Medical Center Polyclinics
VACSERA Medical Center Polyclinics
VACSERA Medical Center Polyclinics
30-Bed Cardiovascular Inpatient Capacity

VACSERA National Heart Center

A state-of-the-art cardiovascular facility dedicated to delivering advanced cardiac care, equipped with modern cardiac catheterization labs, ICU, and inpatient beds.

VACSERA National Heart Center
VACSERA National Heart Center
VACSERA National Heart Center
Therapeutic Area Leader

Allergy and Immunology Center

Specialized clinical and diagnostic hub for immunological assessments, allergy testing, and immunotherapy research protocols.

Allergy and Immunology Center
1,000 m³ — 60 Million Doses (GSP/GDP)

VACSERA Depot & Central Cold Storage

Fully qualified, validated pharmaceutical storage and distribution facility designed to strictly comply with international GSP and GDP guidelines. Accredited temperature-controlled chambers with 24/7 continuous monitoring systems.

VACSERA Depot & Central Cold Storage
VACSERA Depot & Central Cold Storage
VACSERA Depot & Central Cold Storage
Safe Disposal of Hazardous & Cytotoxic Research Waste

Dedicated Incineration Unit

Dedicated, high-efficiency incineration unit serving as the certified final step for the safe disposal of hazardous, cytotoxic, and high-risk clinical research waste.

Dedicated Incineration Unit
Dedicated Incineration Unit
Polio RRL & National Influenza Centre

Two WHO Regional Reference Laboratories

VACSERA proudly hosts two World Health Organization Regional Reference Laboratories: (1) WHO Regional Reference Laboratory for Polio (RRL) and (2) WHO National Influenza Centre (NIC).

Two WHO Regional Reference Laboratories
FLAGSHIP ACHIEVEMENT — COVID-19 LEADERSHIP

Principal Site for Egypt’s First Phase III Mega-Trial for COVID-19 Vaccines

During the global pandemic, VCRC served as the Principal Site for Egypt’s first Phase III Mega-Trial for COVID-19 vaccines. In September 2020, Egypt initiated trials for two Chinese inactivated coronavirus vaccines conducted at VACSERA in cooperation with Chinese and Emirati partners.

Trial Scope

Multi-center Efficacy Study of Inactivated Vaccine

Scale

1,500+ Participants

Outcome

Emergency Use Authorization (EUA) & 100% GCP

“This cooperation demonstrates the team's capacity to operate within strict international standards and handle complex research protocols with excellence.”
COVID-19 Phase III Trial Site
Phase III Mega-Trial Site

COVID-19 Vaccine Clinical Trials at VACSERA

CENTER ACHIEVEMENTS & CLINICAL STUDIES PORTFOLIO

Documented Clinical Trials & Collaborative Research Studies

A legacy of successful clinical trials, bioequivalence studies, and epidemiological surveillance conducted with leading partners.

Vaccines & BiologicalsRandomized Controlled Trial

Tetanus Toxoid (TT) vs Reduced Diphtheria (Td) Randomized Controlled Trial

Open-labelled randomized controlled trial in pregnant women evaluating the equivalency of TT and Td in safety and immunogenicity. Conducted by: VACSERA, NODCAR, MOHP Behera Governorate, and U.S. Naval Medical Research Unit No. 3 (NAMRU-3, Cairo, Egypt).

Vaccines & BiologicalsControlled Clinical Study

Oral & Inactivated Poliovirus Vaccines (Sequential & Combined Immunization)

Controlled study of reactogenicity and immunogenicity evaluating sequential and combined immunization of infants with oral (OPV) and inactivated (IPV) poliovirus vaccines. By: VACSERA.

Surveillance & Post-MarketingPost-Marketing Trial

Post-Marketing Study on Anti-Snake & Anti-Scorpion Polyvalent Antiserum

Post-marketing clinical study evaluating the safety and clinical efficacy of VACSERA polyvalent anti-snake antiserum & anti-scorpion serum. Conducted at the Poison Control Center, Ain Shams University Hospitals, Egypt.

Surveillance & Post-MarketingEPI Surveillance

Expanded Program of Immunization (EPI) Adverse Events Surveillance

Post-marketing surveillance study monitoring adverse events following routine immunization (BCG, OPV, DTPw, HBV, MMR) in children under two years of age in Sharkia Governorate. Conducted by: VACSERA.

Clinical Trials & BioequivalenceEfficacy Trial

Safety & Efficacy of Human Albumin in Cirrhotic Patients (January 2007)

Clinical evaluation of Human Albumin safety and therapeutic efficacy in cirrhotic patients presenting with tense ascites and/or hypoalbuminemia.

Clinical Trials & BioequivalenceBioequivalence Study

Comparative Bioequivalence Study: Human Insulin VACSERA vs Mixtard 30/70

Comparative randomized, single-dose, two-way crossover open-label study to determine the bioequivalence of 30% Short-Acting / 70% Intermediate-Acting NPH Human Insulin (VACSERA SC Injection, Egypt vs Mixtard 30/70 SC Injection, Novo Nordisk, Denmark) in healthy adult volunteers under fasting conditions.

Clinical Trials & BioequivalenceDiagnostic Trial

Tuberculin PPD-2 vs PPD-1 Randomized Controlled Study (July 2006)

Randomized controlled study comparing the clinical safety and diagnostic efficacy of proposed PPD-2 against current PPD-1 in Tuberculin 5 Units.

Specialized Biologicals (Bee Venom)Phase IIa Trial

ABEVAC (Bee Venom) Phase IIa Trial in Rheumatoid Arthritis

Open Phase IIa trial evaluating the safety and therapeutic efficacy of ABEVAC (purified bee venom) in patients with rheumatoid arthritis. Performed jointly between EgyVac and the Pharmacological Department at Kasr El-Ainy, alongside clinical studies by Prof. Dr. Darwish El-Hallous (Alexandria).

Specialized Biologicals (Bee Venom)International Phase II

Apitox for Degenerative Osteoarthritis (Chungbuk National University, Korea)

Phase II randomized active controlled trial evaluating the clinical efficacy of Apitox (purified bee venom solution) in degenerative osteoarthritis patients, in collaboration with the Department of Orthopedic Surgery, College of Medicine, Chungbuk National University, Korea.

International WHO & European TrialsPhase II/III Trial

Silymarin Multi-Center Phase II/III Clinical Study (MADAUS GmbH, Germany)

Multicenter, double-blind, randomized, placebo-controlled Phase II/III trial evaluating the safety and efficacy of 280 mg and 420 mg Silymarin. Sponsor: MADAUS GmbH, Cologne, Germany.

International WHO & European TrialsWHO Geneva Trial

Monovalent Type 1 (mOPV1) vs Trivalent OPV (WHO POL, Geneva - June 2005)

Comparative randomized double-blind trial evaluating the immunogenicity of Monovalent Type 1 Oral Polio Vaccine (mOPV1) versus Trivalent OPV (tOPV) in Egypt. Sponsor: POL, World Health Organization (WHO), Geneva.

International WHO & European TrialsWHO EMRO Study

Poliovirus Antibodies Sero-Survey (WHO EMRO - December 2000)

Comprehensive survey of Poliovirus antibodies conducted during the critical final stage of polio eradication in Egypt. Sponsor: POL, WHO EMRO, Cairo.

CERTIFICATION & LICENSES

Registered by the Supreme Council of Research Ethics

The center was officially registered by the Supreme Council of Research Ethics in August 2025 according to the required regulatory guidelines.

CRE Certificate
View Full Certificate

CRE Registration Certificate

Supreme Council of Research Ethics — August 2025

IRB Certificate
View Full Certificate

IRB Registration Certificate

Institutional Review Board Accreditation

NATIONAL & INTERNATIONAL PARTNERSHIPS

Trusted by Global Health Leaders & Sovereign Bodies

Strong collaborations with international health organizations, universities, and leading pharmaceutical companies.

National Partners & Academic Medical Centers

Ministry of Health and Population (MoHP)Ministry of Health and Population (MoHP)
Egyptian Drug Authority (EDA)Egyptian Drug Authority (EDA)
Kasr El-Ainy — Cairo UniversityKasr El-Ainy — Cairo University
Ain Shams University HospitalsAin Shams University Hospitals

International Partners & Global Organizations

World Health Organization (WHO)World Health Organization (WHO)
SinopharmSinopharm
G42 Healthcare / SinovacG42 Healthcare / Sinovac
U.S. NAMRU-3U.S. NAMRU-3
Chungbuk National University (Korea)Chungbuk National University (Korea)
MADAUS GmbH (Germany)MADAUS GmbH (Germany)
CONTACT US

VACSERA Clinical Research Center (VCRC)

Affiliated to the Holding Company for Biological Products & Vaccines (VACSERA)

We welcome collaborations with vaccine developers, pharmaceutical sponsors, and global health bodies for GCP-compliant clinical trials and bioequivalence investigations.

Address

51, Wezaret El Zeraa St., Agouza, Giza, Egypt

Telephone & Fax

Tel: 02 37611111 - 1060

Fax: 02 - 37609177

Mobile: 01000702476