Plasmodium Falciparum MalariaPhase 1NCT01026246
EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-immune Adults
A Phase 1 study testing EBA-175 RII-NG Malaria Vaccine in people with Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Ghana.
Trial summary
Malaria is caused by a germ that people get from the bites of some mosquitoes. It kills over 2 million people each year. Many of the drugs used to treat malaria do not work as well as they used to and researchers are exploring other vaccines to prevent malaria. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- EBA-175 RII-NG Malaria Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGhana
- Study dates
- Jun 2010to Mar 2012
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and healthy non-pregnant and non breastfeeding females between the ages of 18 and 40 years.
- Females of childbearing potential must agree to practice adequate contraception through out the study and for 3 months after the third vaccination (including abstinence; hormonal contraception; condoms with spermicidal agents); males with female partners of childbearing age must agree to use condoms or other birth control.
- Good health as determined by screening medical history, physical examination (PE), and routine laboratory assessments.
- Willingness to comply with protocol requirements.
- Ability to provide informed consent before any protocol procedures are performed.
- Availability for follow-up for 12 months after the first immunization dose.
Who cannot join
- Regular use of medications other than vitamins and contraceptives.
- Current or recent (within the last 4 weeks prior to vaccination) treatment with parenteral, inhaled, or oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive agents, or chemotherapy.
- History of splenectomy.
- Abnormal screening laboratory values. Any abnormal screening value for any screening test, will exclude the subject from the study. An exception to this rule is the glucose measurement. Random plasma glucose will be measured on all subjects during the screening visit. Values higher than 110 mg/dl will be confirmed by a repeat fasting glucose measurement.
- History of or current medical, occupational, social or family problems as a result of alcohol or illicit drug use by the volunteer.
- History of moderate to severe mental illness, as defined by symptoms interfering with social or occupational function or suicidal thoughts/attempts.
Show all 19Show fewer
- History of receiving blood or blood products (such as blood transfusion, platelet transfusion, immunoglobulins, hyperimmune serum) in the previous 6 months.
- Vaccination with a live vaccine within the past 30 days or with a non-replicating, inactivated, or subunit vaccine within the last 14 days.
- Known hypersensitivity to components of the vaccine [Erythrocyte-Binding Antigen 175 kDa Region II-Nonglycosylated (EBA-175 RII-NG), sucrose, or aluminum adjuvant].
- History of acute or chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic and autoimmune/inflammatory conditions, sickle cell disease.
- History of anaphylaxis or severe hypersensitivity reaction.
- Severe asthma, as defined by an emergency room visit or hospitalization within the last 12 months.
- Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period.
- Acute illness, including temperature > 37.8 degrees Celsius within one week prior to vaccination.
- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg).
- Concurrent participation in other investigational protocols or receipt of an investigational product within the previous 30 days.
- Identification of any condition that, in the opinion of the investigator, would affect the ability of the subject to understand or comply with the study protocol or would jeopardize the safety or rights of a subject participating in the study.
- History of malignancy, including hematologic and skin cancers, or known immunodeficiency syndrome.
- Pre-medication with analgesic or antipyretic in the 6 hours prior to vaccination, or planned medication with analgesic or antipyretic in the 24 hours following vaccination. This criterion should not preclude subjects receiving such medication after vaccination if the need arises.
Trial locations and contacts
1 site in 1 country.
Ghana1 site
Noguchi Memorial Institute for Medical Research - Immunology
Legon, Greater Accra Region
About this study
Official title: Phase I, Double-Blinded, Placebo-Controlled Dosage-Escalation Study of the Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-immune Adults
Malaria is caused by a germ that people get from the bites of some mosquitoes. It kills over 2 million people each year. Many of the drugs used to treat malaria do not work as well as they used to and researchers are exploring other vaccines to prevent malaria. The purpose of this study is to learn if the vaccine, called EBA-175 RII-NG, is safe and if it strengthens the body's defenses against malaria. Participants will include 60 healthy adults, ages 18-40, recruited from Accra, Ghana. Several dosages of the vaccine will be tested for safety. The lowest dosages of the vaccine will be tested before the next higher dose is tested. There will be two groups for each dose, one group will receive the vaccine and the other group will receive a placebo (salt water solution). Participants may be involved in study related procedures for up to 398 days.
Read the detailed description
Malaria accounts for 500 million febrile illnesses and more than a million deaths annually. The disease burden is heaviest in economically developing countries where it is estimated that up to 5 percent of the gross domestic product of sub-Saharan countries is consumed by the direct and indirect health costs of malaria. Researchers propose to conduct a Phase I dosage-escalating study to assess the safety and immunogenicity of 3 different dosages of erythrocyte-binding antigen 175 kDA region II-nonglycosylated (EBA-175 RII-NG) recombinant Plasmodium falciparum (Pf) vaccine adjuvanted with Adju-Phos (aluminum phosphate adjuvant): 5, 20, and 80 micrograms (mcg), given in 3 doses at 0, 1, and 6 months by intramuscular (IM) injection to healthy young adults in a malaria endemic area (semi-immune adults). One dose of vaccine will be given at each time point. The primary objective is to assess the safety and reactogenicity (tolerability) of ascending dosages of EBA-175 RII-NG vaccine among healthy subjects given in 3 IM doses at 0, 1 and 6 months. The secondary objective is to evaluate the immunogenicity of the EBA-175 RII-NG vaccine by measuring anti-EBA-175 RII-NG antibodies using enzyme-linked immunosorbent assay (ELISA), inhibition of Plasmodium falciparum growth in vitro, and inhibition of binding of EBA-175 RII-NG to red blood cells (RBCs). Participants will include 60 malaria semi-immune healthy subjects between the ages of 18 and 40 years, males and females, recruited from Accra, Ghana. Subjects will be randomized to receive 3 doses of the vaccine or saline placebo by the intramuscular route in a 9:1 ratio at 0, 1 and 6 months. The safety and immunogenicity of ascending dosages of the vaccine will be assessed. Eighteen subjects will receive vaccine at each of the following dosage levels: 5, 20, and 80 mcg. Two subjects will receive placebo for each dosage level. Dosage escalation will proceed only after review of the 2-week safety data of the 2 initial doses of the prior dosage level.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- Placebo, EBA-175 RII-NG Malaria Vaccine
- Keywords
- Ghana, malaria, vaccine, Plasmodium falciparum
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The placebo used will be normal saline (0.9 percent NaCl).
EBA-175 RII-NG Malaria VaccineBiological
EBA-175 RII-NG malaria vaccine is supplied as a white, translucent, cloudy, nonparticulate liquid suspension in single-dose clear glass vials pre-mixed with Adju-Phos aluminum phosphate adjuvant. Each 2-mL vial of EBA-175 RII-NG vaccine contains: 0.7 mL (0.5 mL per dose) EBA-175 RII-NG, at the required dose concentration, 5 percent sucrose, 1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant, sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride), and no preservative.
| Study group | Role | What they receive |
|---|---|---|
| Group B: 20 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant | Experimental | 18 subjects to receive 20 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant; 2 subjects to receive placebo. Receives: Drug: Placebo; Biological: EBA-175 RII-NG Malaria Vaccine |
| Group A: 5 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant | Experimental | 18 subjects to receive 5 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant; 2 subjects to receive placebo. Receives: Drug: Placebo; Biological: EBA-175 RII-NG Malaria Vaccine |
| Group C: 80 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant | Experimental | 18 subjects to receive 80 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant; 2 subjects to receive placebo. Receives: Drug: Placebo; Biological: EBA-175 RII-NG Malaria Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing severe (Grade 3) solicited injection site reactions.
Measured: Within 14 days following vaccination.
Number of subjects experiencing severe solicited systemic reactions (Grade 3).
Measured: Within 14 days following vaccination.
Number of subjects experiencing severe (Grade 3) clinical laboratory values.
Measured: Within 14 days following vaccination.
Number of subjects spontaneously reporting adverse events considered associated with the vaccination that are severe (Grade 3).
Measured: Duration of study.
Serious adverse events considered associated with the vaccination.
Measured: Duration of study.
Secondary outcomes (4)
Number of subjects experiencing a 4-fold increase in Anti-EBA-175 RII-NG antibody level (ELISA).
Measured: Days 14, 28, 42, 180 and 194 relative to baseline.
Relative binding inhibition of recombinant EBA-175 RII-NG to human red blood cells in vitro in the presence of serum from immunized individuals.
Measured: Days 0, 14, 28, 42, 180 and 194.
Anti-EBA-175 RII-NG antibody level by enzyme-linked immunosorbent assay (ELISA).
Measured: Days 0, 14, 28, 42, 180 and 194.
Relative growth inhibition of Plasmodium falciparum in human red blood cells cultured in vitro in the presence of serum from immunized individuals.
Measured: Days 0, 14, 28, 42, 180 and 194.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026246
- Sponsor's protocol ID
- 08-0009
- Status last verified
- May 2012
- First submitted
- 3 Dec 2009
- Last updated
- 29 Mar 2013
- Results posted
- No
Publications
Koram KA, Adu B, Ocran J, Karikari YS, Adu-Amankwah S, Ntiri M, Abuaku B, Dodoo D, Gyan B, Kronmann KC, Nkrumah F. Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-Immune Adults: A Phase 1, Double-Blinded Placebo Controlled Dosage Escalation Study. PLoS One. 2016 Sep 19;11(9):e0163066. doi: 10.1371/journal.pone.0163066. eCollection 2016.
PubMed 27644034
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Double-Blinded, Placebo-Controlled Dosage-Escalation Study of the Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-immune Adults
- ClinicalTrials.gov ID
- NCT01026246
- Acronym / sponsor ID
- 08-0009
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Ghana, malaria, vaccine, Plasmodium falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Dec 2009 (estimated)
- 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.
Malaria is caused by a germ that people get from the bites of some mosquitoes. It kills over 2 million people each year. Many of the drugs used to treat malaria do not work as well as they used to and researchers are exploring other vaccines to prevent malaria. The purpose of this study is to learn if the vaccine, called EBA-175 RII-NG, is safe and if it strengthens the body's defenses against malaria. Participants will include 60 healthy adults, ages 18-40, recruited from Accra, Ghana. Several dosages of the vaccine will be tested for safety. The lowest dosages of the vaccine will be tested before the next higher dose is tested. There will be two groups for each dose, one group will receive the vaccine and the other group will receive a placebo (salt water solution). Participants may be involved in study related procedures for up to 398 days.
Detailed description
Malaria accounts for 500 million febrile illnesses and more than a million deaths annually. The disease burden is heaviest in economically developing countries where it is estimated that up to 5 percent of the gross domestic product of sub-Saharan countries is consumed by the direct and indirect health costs of malaria. Researchers propose to conduct a Phase I dosage-escalating study to assess the safety and immunogenicity of 3 different dosages of erythrocyte-binding antigen 175 kDA region II-nonglycosylated (EBA-175 RII-NG) recombinant Plasmodium falciparum (Pf) vaccine adjuvanted with Adju-Phos (aluminum phosphate adjuvant): 5, 20, and 80 micrograms (mcg), given in 3 doses at 0, 1, and 6 months by intramuscular (IM) injection to healthy young adults in a malaria endemic area (semi-immune adults). One dose of vaccine will be given at each time point. The primary objective is to assess the safety and reactogenicity (tolerability) of ascending dosages of EBA-175 RII-NG vaccine among healthy subjects given in 3 IM doses at 0, 1 and 6 months. The secondary objective is to evaluate the immunogenicity of the EBA-175 RII-NG vaccine by measuring anti-EBA-175 RII-NG antibodies using enzyme-linked immunosorbent assay (ELISA), inhibition of Plasmodium falciparum growth in vitro, and inhibition of binding of EBA-175 RII-NG to red blood cells (RBCs). Participants will include 60 malaria semi-immune healthy subjects between the ages of 18 and 40 years, males and females, recruited from Accra, Ghana. Subjects will be randomized to receive 3 doses of the vaccine or saline placebo by the intramuscular route in a 9:1 ratio at 0, 1 and 6 months. The safety and immunogenicity of ascending dosages of the vaccine will be assessed. Eighteen subjects will receive vaccine at each of the following dosage levels: 5, 20, and 80 mcg. Two subjects will receive placebo for each dosage level. Dosage escalation will proceed only after review of the 2-week safety data of the 2 initial doses of the prior dosage level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B: 20 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant | Experimental | Drug: Placebo, Biological: EBA-175 RII-NG Malaria Vaccine18 subjects to receive 20 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant; 2 subjects to receive placebo. |
| Group A: 5 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant | Experimental | Drug: Placebo, Biological: EBA-175 RII-NG Malaria Vaccine18 subjects to receive 5 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant; 2 subjects to receive placebo. |
| Group C: 80 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant | Experimental | Drug: Placebo, Biological: EBA-175 RII-NG Malaria Vaccine18 subjects to receive 80 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant; 2 subjects to receive placebo. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males and healthy non-pregnant and non breastfeeding females between the ages of 18 and 40 years.
- Females of childbearing potential must agree to practice adequate contraception through out the study and for 3 months after the third vaccination (including abstinence; hormonal contraception; condoms with spermicidal agents); males with female partners of childbearing age must agree to use condoms or other birth control.
- Good health as determined by screening medical history, physical examination (PE), and routine laboratory assessments.
- Willingness to comply with protocol requirements.
- Ability to provide informed consent before any protocol procedures are performed.
Key exclusion criteria (19 listed)
- Regular use of medications other than vitamins and contraceptives.
- Current or recent (within the last 4 weeks prior to vaccination) treatment with parenteral, inhaled, or oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive agents, or chemotherapy.
- History of splenectomy.
- Abnormal screening laboratory values. Any abnormal screening value for any screening test, will exclude the subject from the study. An exception to this rule is the glucose measurement. Random plasma glucose will be measured on all subjects during the screening visit. Values higher than 110 mg/dl will be confirmed by a repeat fasting glucose measurement.
- History of or current medical, occupational, social or family problems as a result of alcohol or illicit drug use by the volunteer.
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 |
|---|---|---|
| PlaceboThe placebo used will be normal saline (0.9 percent NaCl). | Drug | Group A: 5 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant, Group B: 20 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant, Group C: 80 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant |
| EBA-175 RII-NG Malaria VaccineEBA-175 RII-NG malaria vaccine is supplied as a white, translucent, cloudy, nonparticulate liquid suspension in single-dose clear glass vials pre-mixed with Adju-Phos aluminum phosphate adjuvant. Each 2-mL vial of EBA-175 RII-NG vaccine contains: 0.7 mL (0.5 mL per dose) EBA-175 RII-NG, at the required dose concentration, 5 percent sucrose, 1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant, sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride), and no preservative. | Biological | Group A: 5 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant, Group B: 20 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant, Group C: 80 mcg EBA-175 + 500 mcg aluminum phosphate adjuvant |
Primary outcome
Number of subjects experiencing severe (Grade 3) solicited injection site reactions.
Time frame: Within 14 days following vaccination.
Number of subjects experiencing severe solicited systemic reactions (Grade 3).
Time frame: Within 14 days following vaccination.
Number of subjects experiencing severe (Grade 3) clinical laboratory values.
Time frame: Within 14 days following vaccination.
Number of subjects spontaneously reporting adverse events considered associated with the vaccination that are severe (Grade 3).
Time frame: Duration of study.
Serious adverse events considered associated with the vaccination.
Time frame: Duration of study.
4 secondary outcomes
Number of subjects experiencing a 4-fold increase in Anti-EBA-175 RII-NG antibody level (ELISA).
Time frame: Days 14, 28, 42, 180 and 194 relative to baseline.
Relative binding inhibition of recombinant EBA-175 RII-NG to human red blood cells in vitro in the presence of serum from immunized individuals.
Time frame: Days 0, 14, 28, 42, 180 and 194.
Anti-EBA-175 RII-NG antibody level by enzyme-linked immunosorbent assay (ELISA).
Time frame: Days 0, 14, 28, 42, 180 and 194.
Relative growth inhibition of Plasmodium falciparum in human red blood cells cultured in vitro in the presence of serum from immunized individuals.
Time frame: Days 0, 14, 28, 42, 180 and 194.
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 29 Mar 2013.
- Derived from this study: PubMed 27644034Koram KA, Adu B, Ocran J, Karikari YS, Adu-Amankwah S, Ntiri M, Abuaku B, Dodoo D, Gyan B, Kronmann KC, Nkrumah F. Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-Immune Adults: A Phase 1, Double-Blinded Placebo Controlled Dosage Escalation Study. PLoS One. 2016 Sep 19;11(9):e0163066. doi: 10.1371/journal.pone.0163066. eCollection 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 EBA-175 RII-NG Malaria Vaccine in people with Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Ghana.
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 6 inclusion and 19 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 29 Mar 2013. 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 Ghana. 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?
Number of subjects experiencing severe (Grade 3) solicited injection site reactions. (time frame: Within 14 days following vaccination.). 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?
On the ClinicalTrials.gov record for NCT01026246, which also lists 1 linked publication.
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 29 Mar 2013.